Trial Outcomes & Findings for A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma (NHL) and in Combination With Endocrine Therapy in Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer (NCT NCT01296555)
NCT ID: NCT01296555
Last Updated: 2024-07-31
Results Overview
A DLT is defined as any one of the following toxicities occurring within the DLT Assessment Window (Days 1-35 of Cycle 1 in Stage 1) assessed by the investigator: Grade ≥ 3 non-hematologic, non-hepatic organ system, non-metabolic (hyperglycemia and hyperlipidemia) toxicity, excluding alopecia of any grade, Grade 3 diarrhea, Grade 3 nausea or vomiting; Grade ≥ 4 thrombocytopenia; Grade ≥ 4 neutropenia lasting \> 5 days or accompanied by fever; Fasting Grade ≥ 4 hyperglycemia or ≥ 3 hyperglycemia for ≥ 1 week; Grade ≥ 4 fasting hypercholesterolemia or triglyceridemia for ≥ 2 weeks; Grade ≥ 3 serum bilirubin or hepatic transaminase (ALT or AST); For participants abnormal at baseline: hepatic transaminase ≥ 7.5 × the upper limit of normal (ULN) or total bilirubin ≥ 5 × the ULN or 10 × the ULN or alkaline phosphatase ≥ 10 times the ULN.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
674 participants
Primary outcome timeframe
Baseline up to 35 days of Cycle 1
Results posted on
2024-07-31
Participant Flow
Participants took part in this study at 30 centers in Canada, France, Spain, and United States from 16 March 2011 to 25 June 2021.
Participant milestones
| Measure |
Phase I, Stage 1: GDC-0032 3 Milligrams (mg) Once
Participants received GDC-0032 3 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 5 mg QD
Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 8 mg QD
Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 12 mg QD
Participants received GDC- 0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28- day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 16 mg QD
Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort A - GDC-0032 9 mg QD
Participants with PIK3CA-mutant breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort B - GDC-0032 9 mg QD
Participants with PIK3CA-mutant solid tumors other than breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort C - GDC-0032 9 mg QD + Midazolam 5 mg
Participants with any type of solid tumors were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD on Days 2 to 29 along with midazolam 5 mg syrup, orally, once on Days 1 and 16 of Cycle 1 (Cycle 1 duration=29 days) followed by GDC-0032 9 mg capsules, orally, QD in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort D - GDC-0032 9 mg QD
Participants with HER2-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 6 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression
|
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestran t 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestran t 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression
|
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression
|
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression
|
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression
|
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
Participants with non-Hodgkin's lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase II: GDC-0032 6 mg QD + Fulvestrant 500 mg
Postmenopausal participants with locally advanced or metastatic HER2-negative, hormone receptor-positive breast cancer who had not previously received fulvestrant were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycles until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
4
|
10
|
11
|
20
|
20
|
13
|
10
|
20
|
8
|
21
|
6
|
21
|
35
|
20
|
20
|
19
|
20
|
27
|
28
|
20
|
20
|
20
|
10
|
10
|
70
|
122
|
60
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
4
|
10
|
11
|
20
|
20
|
13
|
10
|
20
|
8
|
20
|
6
|
21
|
35
|
20
|
20
|
18
|
20
|
27
|
28
|
20
|
20
|
20
|
10
|
10
|
70
|
121
|
60
|
Reasons for withdrawal
| Measure |
Phase I, Stage 1: GDC-0032 3 Milligrams (mg) Once
Participants received GDC-0032 3 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 5 mg QD
Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 8 mg QD
Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 12 mg QD
Participants received GDC- 0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28- day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 16 mg QD
Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort A - GDC-0032 9 mg QD
Participants with PIK3CA-mutant breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort B - GDC-0032 9 mg QD
Participants with PIK3CA-mutant solid tumors other than breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort C - GDC-0032 9 mg QD + Midazolam 5 mg
Participants with any type of solid tumors were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD on Days 2 to 29 along with midazolam 5 mg syrup, orally, once on Days 1 and 16 of Cycle 1 (Cycle 1 duration=29 days) followed by GDC-0032 9 mg capsules, orally, QD in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort D - GDC-0032 9 mg QD
Participants with HER2-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 6 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression
|
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestran t 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestran t 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression
|
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression
|
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression
|
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression
|
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
Participants with non-Hodgkin's lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase II: GDC-0032 6 mg QD + Fulvestrant 500 mg
Postmenopausal participants with locally advanced or metastatic HER2-negative, hormone receptor-positive breast cancer who had not previously received fulvestrant were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycles until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
1
|
2
|
4
|
1
|
4
|
3
|
1
|
0
|
4
|
1
|
4
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Reason Not Specified
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
3
|
7
|
4
|
3
|
7
|
11
|
5
|
5
|
7
|
2
|
2
|
19
|
11
|
9
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Progressive Disease
|
6
|
3
|
3
|
7
|
6
|
16
|
16
|
8
|
7
|
18
|
7
|
14
|
5
|
12
|
1
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
5
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Study Terminated By Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Use Of Another Anti-Cancer Therapy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
2
|
1
|
0
|
2
|
0
|
0
|
1
|
0
|
1
|
0
|
2
|
27
|
15
|
11
|
11
|
17
|
12
|
13
|
12
|
12
|
13
|
7
|
7
|
35
|
92
|
44
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
2
|
0
|
2
|
3
|
2
|
0
|
0
|
0
|
0
|
3
|
13
|
5
|
|
Overall Study
Non-Compliance With Study Drug
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
3
|
0
|
2
|
1
|
0
|
1
|
1
|
1
|
3
|
0
|
0
|
0
|
8
|
4
|
2
|
Baseline Characteristics
A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma (NHL) and in Combination With Endocrine Therapy in Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Phase I, Stage 1: GDC-0032 3 Milligrams (mg) Once
n=6 Participants
Participants received GDC-0032 3 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 5 mg QD
n=3 Participants
Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 8 mg QD
n=4 Participants
Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 12 mg QD
n=10 Participants
Participants received GDC- 0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28- day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 16 mg QD
n=11 Participants
Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort A - GDC-0032 9 mg QD
n=20 Participants
Participants with PIK3CA-mutant breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort B - GDC-0032 9 mg QD
n=20 Participants
Participants with PIK3CA-mutant solid tumors other than breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort C - GDC-0032 9 mg QD + Midazolam 5 mg
n=13 Participants
Participants with any type of solid tumors were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD on Days 2 to 29 along with midazolam 5 mg syrup, orally, once on Days 1 and 16 of Cycle 1 (Cycle 1 duration=29 days) followed by GDC-0032 9 mg capsules, orally, QD in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort D - GDC-0032 9 mg QD
n=10 Participants
Participants with HER2-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 6 mg QD + Letrozole 2.5 mg QD
n=20 Participants
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
n=8 Participants
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression
|
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestran t 500 mg
n=21 Participants
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestran t 500 mg
n=6 Participants
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
n=21 Participants
Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
n=35 Participants
Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
n=20 Participants
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
n=20 Participants
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
n=19 Participants
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
n=20 Participants
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
n=27 Participants
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression
|
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
n=28 Participants
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression
|
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
n=20 Participants
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression
|
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
n=20 Participants
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression
|
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
n=20 Participants
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
n=10 Participants
Participants with non-Hodgkin's lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
n=10 Participants
Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
n=70 Participants
Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
n=122 Participants
Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase II: GDC-0032 6 mg QD + Fulvestrant 500 mg
n=60 Participants
Postmenopausal participants with locally advanced or metastatic HER2-negative, hormone receptor-positive breast cancer who had not previously received fulvestrant were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycles until disease progression.
|
Total
n=674 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.0 Years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
49.0 Years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
66.3 Years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
60.7 Years
STANDARD_DEVIATION 15.4 • n=4 Participants
|
57.9 Years
STANDARD_DEVIATION 11.9 • n=21 Participants
|
56.8 Years
STANDARD_DEVIATION 11.6 • n=8 Participants
|
62.6 Years
STANDARD_DEVIATION 11.9 • n=8 Participants
|
61.7 Years
STANDARD_DEVIATION 9.6 • n=24 Participants
|
50.4 Years
STANDARD_DEVIATION 9.5 • n=42 Participants
|
63.5 Years
STANDARD_DEVIATION 9.7 • n=42 Participants
|
59.1 Years
STANDARD_DEVIATION 7.6 • n=42 Participants
|
59.8 Years
STANDARD_DEVIATION 11.9 • n=42 Participants
|
55.0 Years
STANDARD_DEVIATION 9.7 • n=36 Participants
|
64.4 Years
STANDARD_DEVIATION 10.0 • n=36 Participants
|
64.3 Years
STANDARD_DEVIATION 11.8 • n=24 Participants
|
61.8 Years
STANDARD_DEVIATION 7.7 • n=135 Participants
|
62.8 Years
STANDARD_DEVIATION 9.1 • n=136 Participants
|
54.3 Years
STANDARD_DEVIATION 12.7 • n=44 Participants
|
55.7 Years
STANDARD_DEVIATION 11.9 • n=667 Participants
|
63.1 Years
STANDARD_DEVIATION 9.1 • n=12 Participants
|
59.7 Years
STANDARD_DEVIATION 12.5 • n=12 Participants
|
57.2 Years
STANDARD_DEVIATION 13.9 • n=12 Participants
|
58.3 Years
STANDARD_DEVIATION 8.9 • n=12 Participants
|
59.5 Years
STANDARD_DEVIATION 10.6 • n=11 Participants
|
66.1 Years
STANDARD_DEVIATION 7.8 • n=6 Participants
|
53.9 Years
STANDARD_DEVIATION 19.3 • n=7 Participants
|
60.6 Years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
58.9 Years
STANDARD_DEVIATION 11.9 • n=408 Participants
|
60.3 Years
STANDARD_DEVIATION 12.2 • n=206 Participants
|
59.8 Years
STANDARD_DEVIATION 11.9 • n=16 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
20 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
21 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
16 Participants
n=36 Participants
|
22 Participants
n=24 Participants
|
20 Participants
n=135 Participants
|
20 Participants
n=136 Participants
|
19 Participants
n=44 Participants
|
20 Participants
n=667 Participants
|
27 Participants
n=12 Participants
|
28 Participants
n=12 Participants
|
20 Participants
n=12 Participants
|
20 Participants
n=12 Participants
|
19 Participants
n=11 Participants
|
6 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
37 Participants
n=7 Participants
|
83 Participants
n=408 Participants
|
60 Participants
n=206 Participants
|
544 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
5 Participants
n=36 Participants
|
13 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=11 Participants
|
4 Participants
n=6 Participants
|
8 Participants
n=7 Participants
|
33 Participants
n=7 Participants
|
39 Participants
n=408 Participants
|
0 Participants
n=206 Participants
|
130 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=408 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
2 Participants
n=667 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=408 Participants
|
3 Participants
n=206 Participants
|
18 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=408 Participants
|
3 Participants
n=206 Participants
|
19 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or other Pacific Island
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=408 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
20 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
20 Participants
n=36 Participants
|
30 Participants
n=24 Participants
|
19 Participants
n=135 Participants
|
20 Participants
n=136 Participants
|
17 Participants
n=44 Participants
|
17 Participants
n=667 Participants
|
26 Participants
n=12 Participants
|
27 Participants
n=12 Participants
|
18 Participants
n=12 Participants
|
18 Participants
n=12 Participants
|
20 Participants
n=11 Participants
|
10 Participants
n=6 Participants
|
9 Participants
n=7 Participants
|
57 Participants
n=7 Participants
|
109 Participants
n=408 Participants
|
53 Participants
n=206 Participants
|
612 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=408 Participants
|
0 Participants
n=206 Participants
|
20 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Race · Multiple
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=408 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=408 Participants
|
0 Participants
n=206 Participants
|
26 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
18 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
20 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
18 Participants
n=36 Participants
|
31 Participants
n=24 Participants
|
17 Participants
n=135 Participants
|
20 Participants
n=136 Participants
|
17 Participants
n=44 Participants
|
18 Participants
n=667 Participants
|
24 Participants
n=12 Participants
|
25 Participants
n=12 Participants
|
18 Participants
n=12 Participants
|
19 Participants
n=12 Participants
|
20 Participants
n=11 Participants
|
10 Participants
n=6 Participants
|
8 Participants
n=7 Participants
|
61 Participants
n=7 Participants
|
108 Participants
n=408 Participants
|
56 Participants
n=206 Participants
|
611 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=408 Participants
|
1 Participants
n=206 Participants
|
11 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
3 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=408 Participants
|
3 Participants
n=206 Participants
|
26 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 35 days of Cycle 1Population: The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
A DLT is defined as any one of the following toxicities occurring within the DLT Assessment Window (Days 1-35 of Cycle 1 in Stage 1) assessed by the investigator: Grade ≥ 3 non-hematologic, non-hepatic organ system, non-metabolic (hyperglycemia and hyperlipidemia) toxicity, excluding alopecia of any grade, Grade 3 diarrhea, Grade 3 nausea or vomiting; Grade ≥ 4 thrombocytopenia; Grade ≥ 4 neutropenia lasting \> 5 days or accompanied by fever; Fasting Grade ≥ 4 hyperglycemia or ≥ 3 hyperglycemia for ≥ 1 week; Grade ≥ 4 fasting hypercholesterolemia or triglyceridemia for ≥ 2 weeks; Grade ≥ 3 serum bilirubin or hepatic transaminase (ALT or AST); For participants abnormal at baseline: hepatic transaminase ≥ 7.5 × the upper limit of normal (ULN) or total bilirubin ≥ 5 × the ULN or 10 × the ULN or alkaline phosphatase ≥ 10 times the ULN.
Outcome measures
| Measure |
Cohorts T and T2
n=6 Participants
Participants from Cohorts T and T2 of Phase I, Stage 2 were included in this analysis.
|
Phase I, Stage 1: GDC-0032 5 mg QD
n=3 Participants
Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 8 mg QD
n=4 Participants
Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 12 mg QD
n=10 Participants
Participants received GDC-0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 16 mg QD
n=11 Participants
Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
Participants with non-Hodgkin's lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase I Stage 1: Percentage of Participants With Dose-Limiting Toxicities (DLTs) as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
10.0 percentage of participants
|
18.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to 28 days of Cycle 1Population: The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
A DLT is defined as any one of the following toxicities occurring within the DLT Assessment Window (Days 1-28 of Cycle 1 in Stage 1) assessed by the investigator: Grade ≥ 3 non-hematologic, non-hepatic organ system, non-metabolic (hyperglycemia and hyperlipidemia) toxicity, excluding alopecia of any grade, Grade 3 diarrhea, Grade 3 nausea or vomiting; Grade ≥ 4 thrombocytopenia; Grade ≥ 4 neutropenia lasting \> 5 days or accompanied by fever; Fasting Grade ≥ 4 hyperglycemia or ≥ 3 hyperglycemia for ≥ 1 week; Grade ≥ 4 fasting hypercholesterolemia or triglyceridemia for ≥ 2 weeks; Grade ≥ 3 serum bilirubin or hepatic transaminase (ALT or AST); For participants abnormal at baseline: hepatic transaminase ≥ 7.5 × ULN or total bilirubin ≥ 5 × the ULN or 10 × the ULN or alkaline phosphatase ≥ 10 times the ULN.
Outcome measures
| Measure |
Cohorts T and T2
n=20 Participants
Participants from Cohorts T and T2 of Phase I, Stage 2 were included in this analysis.
|
Phase I, Stage 1: GDC-0032 5 mg QD
n=8 Participants
Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 8 mg QD
n=21 Participants
Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 12 mg QD
n=6 Participants
Participants received GDC-0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 16 mg QD
Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
Participants with non-Hodgkin's lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase I Stage 2 Cohorts E and F: Percentage of Participants With DLTs as Assessed by NCI CTCAE v4.0
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1, Day 1: Pre-dose (0-2 hours [hr]), 0.5, 1, 2, 3, 4, 8, 24, 48 and 72 hr; Day 15: Pre-dose (0-2 hr), 0.5, 1, 2, 3, 4, 8 and 24 hrPopulation: The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant. 'Number Analyzed' signifies number of participants analyzed for this outcome measure at the specified timepoint.
The concentrations are in micromole (µM), and the molecular weight of GDC-0032 is 460.53 g/mol.
Outcome measures
| Measure |
Cohorts T and T2
n=6 Participants
Participants from Cohorts T and T2 of Phase I, Stage 2 were included in this analysis.
|
Phase I, Stage 1: GDC-0032 5 mg QD
n=3 Participants
Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 8 mg QD
n=4 Participants
Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 12 mg QD
n=10 Participants
Participants received GDC-0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 16 mg QD
n=11 Participants
Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
Participants with non-Hodgkin's lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase I: AUC From Zero to Tau (AUCtau) of GDC-0032
Day 15
|
1.79 micromolar per hour (µM*h)
Standard Deviation 0.962
|
1.49 micromolar per hour (µM*h)
Standard Deviation 0.786
|
3.21 micromolar per hour (µM*h)
Standard Deviation 1.636
|
5.1 micromolar per hour (µM*h)
Standard Deviation 2.035
|
8.1 micromolar per hour (µM*h)
Standard Deviation 4.790
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase I: AUC From Zero to Tau (AUCtau) of GDC-0032
Day 1
|
0.441 micromolar per hour (µM*h)
Standard Deviation 0.142
|
0.547 micromolar per hour (µM*h)
Standard Deviation 0.233
|
1.34 micromolar per hour (µM*h)
Standard Deviation 0.411
|
1.8 micromolar per hour (µM*h)
Standard Deviation 0.631
|
2.26 micromolar per hour (µM*h)
Standard Deviation 0.806
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1, Day 1: Pre-dose (0-2 hours [hr]), 0.5, 1, 2, 3, 4, 8, 24, 48 and 72 hr; Day 15: Pre-dose (0-2 hr), 0.5, 1, 2, 3, 4, 8 and 24 hrPopulation: The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant. 'Number Analyzed' signifies number of participants analyzed for this outcome measure at the specified timepoint.
The concentrations are in micromole (µM), and the molecular weight of GDC-0032 is 460.53 g/mol.
Outcome measures
| Measure |
Cohorts T and T2
n=6 Participants
Participants from Cohorts T and T2 of Phase I, Stage 2 were included in this analysis.
|
Phase I, Stage 1: GDC-0032 5 mg QD
n=3 Participants
Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 8 mg QD
n=4 Participants
Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 12 mg QD
n=10 Participants
Participants received GDC-0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 16 mg QD
n=11 Participants
Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
Participants with non-Hodgkin's lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase I: Maximum Observed Plasma Concentration (Cmax) of GDC-0032
Day 1
|
0.0256 micromolar (µM)
Standard Deviation 0.0094
|
0.0304 micromolar (µM)
Standard Deviation 0.0122
|
0.0764 micromolar (µM)
Standard Deviation 0.0328
|
0.127 micromolar (µM)
Standard Deviation 0.0529
|
0.134 micromolar (µM)
Standard Deviation 0.0535
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase I: Maximum Observed Plasma Concentration (Cmax) of GDC-0032
Day 15
|
0.111 micromolar (µM)
Standard Deviation 0.072
|
0.091 micromolar (µM)
Standard Deviation 0.048
|
0.188 micromolar (µM)
Standard Deviation 0.119
|
0.302 micromolar (µM)
Standard Deviation 0.100
|
0.441 micromolar (µM)
Standard Deviation 0.251
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1, Day 1: Pre-dose (0-2 hours [hr]), 0.5, 1, 2, 3, 4, 8, 24, 48 and 72 hrPopulation: The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
Outcome measures
| Measure |
Cohorts T and T2
n=6 Participants
Participants from Cohorts T and T2 of Phase I, Stage 2 were included in this analysis.
|
Phase I, Stage 1: GDC-0032 5 mg QD
n=3 Participants
Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 8 mg QD
n=4 Participants
Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 12 mg QD
n=10 Participants
Participants received GDC-0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 16 mg QD
n=11 Participants
Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
Participants with non-Hodgkin's lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase I: Time to Reach Cmax (Tmax) of GDC-0032
|
4 hours (hr)
Interval 3.0 to 8.0
|
8 hours (hr)
Interval 3.0 to 8.0
|
4 hours (hr)
Interval 2.0 to 4.0
|
3 hours (hr)
Interval 1.0 to 8.0
|
4 hours (hr)
Interval 2.0 to 24.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1, Day 1: Pre-dose (0-2 hours [hr]), 0.5, 1, 2, 3, 4, 8, 24, 48 and 72 hrPopulation: The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
Outcome measures
| Measure |
Cohorts T and T2
n=6 Participants
Participants from Cohorts T and T2 of Phase I, Stage 2 were included in this analysis.
|
Phase I, Stage 1: GDC-0032 5 mg QD
n=3 Participants
Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 8 mg QD
n=4 Participants
Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 12 mg QD
n=10 Participants
Participants received GDC-0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 16 mg QD
n=11 Participants
Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
Participants with non-Hodgkin's lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase I: Terminal Half-life (t1/2) of GDC-0032
|
43.8 hr
Standard Deviation 11.6
|
40 hr
Standard Deviation 21.0
|
38.2 hr
Standard Deviation 9.1
|
36.7 hr
Standard Deviation 8.3
|
39.7 hr
Standard Deviation 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to disease progression or death, whichever occurred first (up to a maximum of 67 months)Population: The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
BOR was defined as having best objective response as complete response (CR) or partial response (PR), as assessed by RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
Outcome measures
| Measure |
Cohorts T and T2
n=674 Participants
Participants from Cohorts T and T2 of Phase I, Stage 2 were included in this analysis.
|
Phase I, Stage 1: GDC-0032 5 mg QD
Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 8 mg QD
Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 12 mg QD
Participants received GDC-0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 16 mg QD
Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
Participants with non-Hodgkin's lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Across All Cohorts (Except Cohorts T and T2): Percentage of Participants With Best Overall Response (BOR) as Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
|
11.4 percentage of participants
Interval 9.1 to 14.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to disease progression or death, whichever occurred first (up to a maximum of 67 months)Population: The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
DOR was defined as the time from the first occurrence of a documented objective response (OR) to progressive disease (PD) or death from any cause (whichever occurred first) as determined by the investigator according to RECIST v1.1. OR=CR+PR. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm. Number of participants analyzed signifies the number of responders.
Outcome measures
| Measure |
Cohorts T and T2
n=77 Participants
Participants from Cohorts T and T2 of Phase I, Stage 2 were included in this analysis.
|
Phase I, Stage 1: GDC-0032 5 mg QD
Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 8 mg QD
Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 12 mg QD
Participants received GDC-0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 16 mg QD
Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
Participants with non-Hodgkin's lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Across All Cohorts (Except Cohorts T and T2): Duration of Objective Response (DOR) as Assessed Using RECIST v1.1
|
NA months
N/A due to insufficient number of responders and insufficient amount of time passed to measure DOR.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to disease progression or death, whichever occurred first (up to a maximum of 67 months)Population: The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause (whichever occurred first), as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Outcome measures
| Measure |
Cohorts T and T2
n=674 Participants
Participants from Cohorts T and T2 of Phase I, Stage 2 were included in this analysis.
|
Phase I, Stage 1: GDC-0032 5 mg QD
Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 8 mg QD
Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 12 mg QD
Participants received GDC-0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 16 mg QD
Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
Participants with non-Hodgkin's lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Across All Cohorts (Except Cohorts T and T2): Progression-Free Survival (PFS) as Assessed Using RECIST v1.1
|
3.7 months
Interval 3.6 to 4.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to disease progression or death, whichever occurs first (up to a maximum of 46 months)Population: The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
BOR in Cohort T was assessed using the 2007 Revised International Working Group (IWG) Response Criteria in Malignant Lymphoma while in Cohort T2, BOR was assessed using the Modified Version of 2014 Lugano Response Criteria in Malignant Lymphoma.
Outcome measures
| Measure |
Cohorts T and T2
n=20 Participants
Participants from Cohorts T and T2 of Phase I, Stage 2 were included in this analysis.
|
Phase I, Stage 1: GDC-0032 5 mg QD
Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 8 mg QD
Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 12 mg QD
Participants received GDC-0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 16 mg QD
Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
Participants with non-Hodgkin's lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With BOR in Cohort T and T2
|
20.0 percentage of participants
Interval 5.7 to 43.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to disease progression or death, whichever occurs first (up to a maximum of 46 months)Population: The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
DOR in Cohort T was assessed using the 2007 Revised IWG Response Criteria in Malignant Lymphoma while in Cohort T2, it was assessed using the Modified Version of 2014 Lugano Response Criteria in Malignant Lymphoma. Number of participants analyzed signifies the number of responders.
Outcome measures
| Measure |
Cohorts T and T2
n=4 Participants
Participants from Cohorts T and T2 of Phase I, Stage 2 were included in this analysis.
|
Phase I, Stage 1: GDC-0032 5 mg QD
Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 8 mg QD
Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 12 mg QD
Participants received GDC-0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 16 mg QD
Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
Participants with non-Hodgkin's lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
DOR in Cohort T and T2
|
NA months
N/A due to insufficient number of responders and insufficient amount of time passed to measure DOR.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to disease progression or death, whichever occurs first (up to a maximum of 46 months)Population: The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
PFS in Cohort T was assessed using the 2007 Revised IWG Response Criteria in Malignant Lymphoma while in Cohort T2, it was assessed using the Modified Version of 2014 Lugano Response Criteria in Malignant Lymphoma.
Outcome measures
| Measure |
Cohorts T and T2
n=20 Participants
Participants from Cohorts T and T2 of Phase I, Stage 2 were included in this analysis.
|
Phase I, Stage 1: GDC-0032 5 mg QD
Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 8 mg QD
Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 12 mg QD
Participants received GDC-0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 16 mg QD
Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
Participants with non-Hodgkin's lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PFS in Cohort T and T2
|
4.2 months
Interval 1.8 to
Upper limit of 95% confidence interval (CI) was not estimable due to low number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to a maximum of 16 months)Population: The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. An SAE is any AE that is fatal, life-threatening, requires or prolongs inpatient hospitalization or results in persistent or significant disability/incapacity, a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product(s) or considered a significant medical event by the investigator.
Outcome measures
| Measure |
Cohorts T and T2
n=6 Participants
Participants from Cohorts T and T2 of Phase I, Stage 2 were included in this analysis.
|
Phase I, Stage 1: GDC-0032 5 mg QD
n=3 Participants
Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 8 mg QD
n=4 Participants
Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 12 mg QD
n=10 Participants
Participants received GDC-0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 16 mg QD
n=11 Participants
Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
Participants with non-Hodgkin's lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase I Stage 1: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) by NCI CTCAE v4.0 Grade
AEs
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase I Stage 1: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) by NCI CTCAE v4.0 Grade
SAEs
|
16.7 percentage of participants
|
0 percentage of participants
|
50.0 percentage of participants
|
40.0 percentage of participants
|
81.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to a maximum of 67 months)Population: The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP or other protocol-imposed intervention, regardless of attribution. An SAE is any AE that is fatal, life-threatening, requires or prolongs inpatient hospitalization or results in persistent or significant disability/incapacity, a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product(s) or considered a significant medical event by the investigator.
Outcome measures
| Measure |
Cohorts T and T2
n=20 Participants
Participants from Cohorts T and T2 of Phase I, Stage 2 were included in this analysis.
|
Phase I, Stage 1: GDC-0032 5 mg QD
n=20 Participants
Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 8 mg QD
n=13 Participants
Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 12 mg QD
n=10 Participants
Participants received GDC-0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 16 mg QD
n=20 Participants
Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
n=8 Participants
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestrant 500 mg
n=21 Participants
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestrant 500 mg
n=6 Participants
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
n=21 Participants
Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
n=35 Participants
Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
n=20 Participants
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
n=20 Participants
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
n=19 Participants
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
n=20 Participants
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
n=27 Participants
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
n=28 Participants
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
n=20 Participants
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
n=20 Participants
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
n=20 Participants
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
n=10 Participants
Participants with non-Hodgkin's lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
n=10 Participants
Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
n=70 Participants
Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
n=122 Participants
Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase I Stage 2: Percentage of Participants With AEs and SAEs by NCI CTCAE v4.0 Grade
AEs
|
100.0 percentage of participants
|
100.0 percentage of participants
|
92.3 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
87.5 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
95.0 percentage of participants
|
95.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
96.4 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
95.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
99.2 percentage of participants
|
|
Phase I Stage 2: Percentage of Participants With AEs and SAEs by NCI CTCAE v4.0 Grade
SAEs
|
45.0 percentage of participants
|
35.0 percentage of participants
|
53.8 percentage of participants
|
40.0 percentage of participants
|
55.0 percentage of participants
|
25.0 percentage of participants
|
23.8 percentage of participants
|
50.0 percentage of participants
|
42.9 percentage of participants
|
54.3 percentage of participants
|
20.0 percentage of participants
|
35.0 percentage of participants
|
15.8 percentage of participants
|
30.0 percentage of participants
|
22.2 percentage of participants
|
35.7 percentage of participants
|
10.0 percentage of participants
|
25.0 percentage of participants
|
10.0 percentage of participants
|
70.0 percentage of participants
|
40.0 percentage of participants
|
57.1 percentage of participants
|
51.6 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to a maximum of 54 months)Population: The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP or other protocol-imposed intervention, regardless of attribution. An SAE is any AE that is fatal, life-threatening, requires or prolongs inpatient hospitalization or results in persistent or significant disability/incapacity, a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product(s) or considered a significant medical event by the investigator.
Outcome measures
| Measure |
Cohorts T and T2
n=60 Participants
Participants from Cohorts T and T2 of Phase I, Stage 2 were included in this analysis.
|
Phase I, Stage 1: GDC-0032 5 mg QD
Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 8 mg QD
Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 12 mg QD
Participants received GDC-0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 16 mg QD
Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
Participants with non-Hodgkin's lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase II: Percentage of Participants With AEs and SAEs by NCI CTCAE v4.0 Grade
AEs
|
100.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase II: Percentage of Participants With AEs and SAEs by NCI CTCAE v4.0 Grade
SAEs
|
31.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to a maximum of 67 monthsPopulation: The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
Laboratory parameters such as fasting glucose, absolute neutrophil count, hemoglobin, platelet count, lymphocytes, serum creatinine, aspartate aminotransferase (AST), alanine transaminase (ALT), leukocytes, fasting triglycerides and fasting cholesterol were assessed. A clinically relevant shift from baseline was defined as a shift from Grade 0, 1, or 2 at baseline to Grade 3 or 4 post baseline.
Outcome measures
| Measure |
Cohorts T and T2
n=365 Participants
Participants from Cohorts T and T2 of Phase I, Stage 2 were included in this analysis.
|
Phase I, Stage 1: GDC-0032 5 mg QD
n=143 Participants
Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 8 mg QD
n=166 Participants
Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 12 mg QD
Participants received GDC-0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 16 mg QD
Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
Participants with non-Hodgkin's lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Clinically Relevant Shifts From Baseline in Laboratory Parameters
High Fasting Glucose
|
9.3 percentage of participants
|
4.9 percentage of participants
|
3.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Clinically Relevant Shifts From Baseline in Laboratory Parameters
Low Fasting Glucose
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Clinically Relevant Shifts From Baseline in Laboratory Parameters
Low Absolute Neutrophil Count
|
4.8 percentage of participants
|
0 percentage of participants
|
0.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Clinically Relevant Shifts From Baseline in Laboratory Parameters
High Hemoglobin
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Clinically Relevant Shifts From Baseline in Laboratory Parameters
Low Hemoglobin
|
5.2 percentage of participants
|
0.7 percentage of participants
|
1.2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Clinically Relevant Shifts From Baseline in Laboratory Parameters
Low Platelet Count
|
1.5 percentage of participants
|
0.7 percentage of participants
|
0.6 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Clinically Relevant Shifts From Baseline in Laboratory Parameters
High Lymphocytes
|
0 percentage of participants
|
0.9 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Clinically Relevant Shifts From Baseline in Laboratory Parameters
Low Lymphocytes
|
13.9 percentage of participants
|
7.3 percentage of participants
|
2.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Clinically Relevant Shifts From Baseline in Laboratory Parameters
High Serum Creatinine
|
0.9 percentage of participants
|
0 percentage of participants
|
2.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Clinically Relevant Shifts From Baseline in Laboratory Parameters
High AST
|
2.6 percentage of participants
|
6.3 percentage of participants
|
7.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Clinically Relevant Shifts From Baseline in Laboratory Parameters
High ALT
|
2.0 percentage of participants
|
4.2 percentage of participants
|
5.2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Clinically Relevant Shifts From Baseline in Laboratory Parameters
High Leukocytes
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Clinically Relevant Shifts From Baseline in Laboratory Parameters
Low Leukocytes
|
2.1 percentage of participants
|
1.4 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Clinically Relevant Shifts From Baseline in Laboratory Parameters
High Fasting Triglycerides
|
0.4 percentage of participants
|
0.9 percentage of participants
|
0.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Clinically Relevant Shifts From Baseline in Laboratory Parameters
High Fasting Cholesterol
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1: Pre-dose (0-2 hr), 1, 2, 3, 4, 8, and 24 hrPopulation: The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
For dosing under fed conditions, participant fasted overnight for \>/= 10 hours before the standard high-fat meal provided at the study site. Participants started the standard high fat meal 30 minutes prior to administration of GDC-0032.
Outcome measures
| Measure |
Cohorts T and T2
n=20 Participants
Participants from Cohorts T and T2 of Phase I, Stage 2 were included in this analysis.
|
Phase I, Stage 1: GDC-0032 5 mg QD
Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 8 mg QD
Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 12 mg QD
Participants received GDC-0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 16 mg QD
Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
Participants with non-Hodgkin's lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of GDC-0032 Under Fed Conditions
|
0.082 µM
Standard Deviation 0.038
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1: Pre-dose (0-2 hr), 1, 2, 3, 4, 8, and 24 hrPopulation: The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
Participants fasted overnight for at least 10 hours before dosing and 4 hours postdose.
Outcome measures
| Measure |
Cohorts T and T2
n=20 Participants
Participants from Cohorts T and T2 of Phase I, Stage 2 were included in this analysis.
|
Phase I, Stage 1: GDC-0032 5 mg QD
Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 8 mg QD
Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 12 mg QD
Participants received GDC-0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 16 mg QD
Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
Participants with non-Hodgkin's lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of GDC-0032 Under Fasted Conditions
|
0.085 µM
Standard Deviation 0.046
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1: Pre-dose (0-2 hr), 1, 2, 3, 4, 8, and 24 hrPopulation: The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
For dosing under fed conditions, participant fasted overnight for \>/= 10 hours before the standard high-fat meal provided at the study site. Participants started the standard high fat meal 30 minutes prior to administration of GDC-0032.
Outcome measures
| Measure |
Cohorts T and T2
n=20 Participants
Participants from Cohorts T and T2 of Phase I, Stage 2 were included in this analysis.
|
Phase I, Stage 1: GDC-0032 5 mg QD
Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 8 mg QD
Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 12 mg QD
Participants received GDC-0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 16 mg QD
Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
Participants with non-Hodgkin's lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC of GDC-0032 Under Fed Conditions
|
1.404 µM*hr
Standard Deviation 0.656
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1: Pre-dose (0-2 hr), 1, 2, 3, 4, 8, and 24 hrPopulation: The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
Participants fasted overnight for at least 10 hours before dosing and 4 hours postdose.
Outcome measures
| Measure |
Cohorts T and T2
n=20 Participants
Participants from Cohorts T and T2 of Phase I, Stage 2 were included in this analysis.
|
Phase I, Stage 1: GDC-0032 5 mg QD
Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 8 mg QD
Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 12 mg QD
Participants received GDC-0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 16 mg QD
Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
Participants with non-Hodgkin's lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC of GDC-0032 Under Fasted Conditions
|
1.247 µM*hr
Standard Deviation 0.911
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1: Pre-dose (0-2 hr), 0.5, 1, 1.5, 2, 4, 8, 24 hr; Day 16: Pre-dose (0-2 hr), 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hrPopulation: The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
The geometric mean ratio (90% CI) for midazolam+ GDC-0032 relative to midazolam alone was reported. Geometric Mean Ratio of Cmax was determined by comparing Midazolam Geometric Mean on Day 16 to Midazolam Geometric Mean on Day 1 (GeoMeanD16/GeoMeanD1).
Outcome measures
| Measure |
Cohorts T and T2
n=13 Participants
Participants from Cohorts T and T2 of Phase I, Stage 2 were included in this analysis.
|
Phase I, Stage 1: GDC-0032 5 mg QD
Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 8 mg QD
Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 12 mg QD
Participants received GDC-0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 16 mg QD
Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
Participants with non-Hodgkin's lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratio of Cmax for Midazolam Plus GDC-0032 Relative to Cmax for Midazolam Alone
|
0.98 ratio
Interval 0.7 to 1.37
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1: Pre-dose (0-2 hr), 0.5, 1, 1.5, 2, 4, 8, 24 hr; Day 16: Pre-dose (0-2 hr), 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hrPopulation: The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
The geometric mean ratios (90% CIs) for midazolam + GDC-0032 relative to midazolam alone were reported. Geometric Mean Ratio is determined by comparing GeoMean of AUC D16 with GeoMean of AUC D1 (GeoMeanD16/GeoMeanD1).
Outcome measures
| Measure |
Cohorts T and T2
n=13 Participants
Participants from Cohorts T and T2 of Phase I, Stage 2 were included in this analysis.
|
Phase I, Stage 1: GDC-0032 5 mg QD
Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 8 mg QD
Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 12 mg QD
Participants received GDC-0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 16 mg QD
Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
Participants with non-Hodgkin's lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratio of AUC for Midazolam Plus GDC-0032 Relative to AUC for Midazolam Alone
|
1.04 ratio
Interval 0.68 to 1.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase I, Stage 1: GDC-0032 3 Milligrams (mg) Once
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase I, Stage 1: GDC-0032 5 mg QD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I, Stage 1: GDC-0032 8 mg QD
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase I, Stage 1: GDC-0032 12 mg QD
Serious events: 4 serious events
Other events: 10 other events
Deaths: 2 deaths
Phase I, Stage 1: GDC-0032 16 mg QD
Serious events: 9 serious events
Other events: 11 other events
Deaths: 1 deaths
Phase I, Stage 2: Cohort A - GDC-0032 9 mg QD
Serious events: 9 serious events
Other events: 20 other events
Deaths: 0 deaths
Phase I, Stage 2: Cohort B - GDC-0032 9 mg QD
Serious events: 7 serious events
Other events: 19 other events
Deaths: 2 deaths
Phase I, Stage 2: Cohort C - GDC-0032 9 mg QD + Midazolam 5 mg
Serious events: 7 serious events
Other events: 12 other events
Deaths: 0 deaths
Phase I, Stage 2: Cohort D - GDC-0032 9 mg QD
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Phase I, Stage 2: Cohort E - GDC-0032 6 mg QD + Letrozole 2.5 mg QD
Serious events: 11 serious events
Other events: 20 other events
Deaths: 1 deaths
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestran t 500 mg
Serious events: 5 serious events
Other events: 21 other events
Deaths: 1 deaths
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestran t 500 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
Serious events: 9 serious events
Other events: 21 other events
Deaths: 3 deaths
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
Serious events: 19 serious events
Other events: 35 other events
Deaths: 27 deaths
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
Serious events: 4 serious events
Other events: 19 other events
Deaths: 15 deaths
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
Serious events: 7 serious events
Other events: 19 other events
Deaths: 11 deaths
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
Serious events: 3 serious events
Other events: 19 other events
Deaths: 11 deaths
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
Serious events: 6 serious events
Other events: 20 other events
Deaths: 17 deaths
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
Serious events: 6 serious events
Other events: 27 other events
Deaths: 12 deaths
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
Serious events: 10 serious events
Other events: 27 other events
Deaths: 13 deaths
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
Serious events: 2 serious events
Other events: 20 other events
Deaths: 12 deaths
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
Serious events: 5 serious events
Other events: 20 other events
Deaths: 12 deaths
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
Serious events: 2 serious events
Other events: 19 other events
Deaths: 13 deaths
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
Serious events: 7 serious events
Other events: 10 other events
Deaths: 7 deaths
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
Serious events: 4 serious events
Other events: 10 other events
Deaths: 7 deaths
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
Serious events: 40 serious events
Other events: 69 other events
Deaths: 35 deaths
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
Serious events: 63 serious events
Other events: 117 other events
Deaths: 92 deaths
Phase II: GDC-0032 6 mg QD + Fulvestrant 500 mg
Serious events: 19 serious events
Other events: 60 other events
Deaths: 44 deaths
Serious adverse events
| Measure |
Phase I, Stage 1: GDC-0032 3 Milligrams (mg) Once
n=6 participants at risk
Participants received GDC-0032 3 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 5 mg QD
n=3 participants at risk
Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 8 mg QD
n=4 participants at risk
Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 12 mg QD
n=10 participants at risk
Participants received GDC- 0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28- day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 16 mg QD
n=11 participants at risk
Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort A - GDC-0032 9 mg QD
n=20 participants at risk
Participants with PIK3CA-mutant breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort B - GDC-0032 9 mg QD
n=20 participants at risk
Participants with PIK3CA-mutant solid tumors other than breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort C - GDC-0032 9 mg QD + Midazolam 5 mg
n=13 participants at risk
Participants with any type of solid tumors were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD on Days 2 to 29 along with midazolam 5 mg syrup, orally, once on Days 1 and 16 of Cycle 1 (Cycle 1 duration=29 days) followed by GDC-0032 9 mg capsules, orally, QD in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort D - GDC-0032 9 mg QD
n=10 participants at risk
Participants with HER2-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 6 mg QD + Letrozole 2.5 mg QD
n=20 participants at risk
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
n=8 participants at risk
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression
|
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestran t 500 mg
n=21 participants at risk
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestran t 500 mg
n=6 participants at risk
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
n=21 participants at risk
Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
n=35 participants at risk
Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
n=20 participants at risk
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
n=20 participants at risk
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
n=19 participants at risk
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
n=20 participants at risk
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
n=27 participants at risk
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression
|
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
n=28 participants at risk
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression
|
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
n=20 participants at risk
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression
|
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
n=20 participants at risk
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression
|
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
n=20 participants at risk
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
n=10 participants at risk
Participants with non-Hodgkin's lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
n=10 participants at risk
Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
n=70 participants at risk
Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
n=122 participants at risk
Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase II: GDC-0032 6 mg QD + Fulvestrant 500 mg
n=60 participants at risk
Postmenopausal participants with locally advanced or metastatic HER2-negative, hormone receptor-positive breast cancer who had not previously received fulvestrant were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycles until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
CENTRAL NERVOUS SYSTEM LESION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
7/122 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
6/60 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
GASTROINTESTINAL VASCULAR MALFORMATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
DEATH
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.1%
5/122 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
3/60 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
UROSEPSIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Eye disorders
PAPILLOEDEMA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.1%
5/122 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
COLITIS MICROSCOPIC
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
18.2%
2/11 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.7%
3/28 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
30.0%
3/10 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.3%
3/70 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
7/122 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
DUODENAL PERFORATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
ENTERITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
SEIZURE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.5%
3/122 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Cardiac disorders
VENTRICULAR ARRHYTHMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Cardiac disorders
MITRAL VALVE DISEASE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Cardiac disorders
STRESS CARDIOMYOPATHY
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Cardiac disorders
VENTRICULAR TACHYARRHYTHMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
GASTROINTESTINAL NECROSIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
ASTHENIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
JEJUNAL PERFORATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
LARGE INTESTINAL STENOSIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
NARCOTIC BOWEL SYNDROME
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
NEUTROPENIC COLITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
PEPTIC ULCER PERFORATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
SUBILEUS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
4/122 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
GASTROINTESTINAL FISTULA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
FATIGUE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
MUCOSAL INFLAMMATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
PYREXIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
SOFT TISSUE INFLAMMATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
SUDDEN DEATH
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Hepatobiliary disorders
BILIARY OBSTRUCTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Hepatobiliary disorders
CHOLANGITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Hepatobiliary disorders
JAUNDICE CHOLESTATIC
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Hepatobiliary disorders
PORTAL HYPERTENSION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
ABDOMINAL INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
ABDOMINAL WALL ABSCESS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
BACTERAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
BRAIN ABSCESS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
CHEST WALL ABSCESS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
DENGUE FEVER
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
ENDOCARDITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
ENTEROBACTER INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
GASTRIC INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
KLEBSIELLA INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
LOCALISED INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
PAROTITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
PERITONITIS BACTERIAL
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
PSEUDOMONAS INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
VARICELLA ZOSTER VIRUS INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
VASCULAR DEVICE INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
STREPTOCOCCAL BACTERAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
STAPHYLOCOCCAL BACTERAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
TOOTH ABSCESS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Injury, poisoning and procedural complications
TIBIA FRACTURE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Injury, poisoning and procedural complications
TRACHEAL HAEMORRHAGE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Injury, poisoning and procedural complications
VASCULAR PSEUDOANEURYSM
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
AMYLASE INCREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
LIPASE INCREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
TRANSAMINASES INCREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
18.2%
2/11 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
4/122 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
WOUND INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
HYPOVOLAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT PLEURAL EFFUSION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Reproductive system and breast disorders
FEMALE GENITAL TRACT FISTULA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Reproductive system and breast disorders
OVARIAN CYST RUPTURED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Reproductive system and breast disorders
PROSTATITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
ATAXIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
BRAIN OEDEMA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
EPILEPSY
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
FACIAL NERVE DISORDER
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Renal and urinary disorders
URETERIC DILATATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Renal and urinary disorders
URETHRAL OBSTRUCTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
ANOXIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.3%
3/70 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.1%
5/122 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL HAEMORRHAGE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
LUNG INFILTRATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY TOXICITY
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Vascular disorders
ARTERIAL RUPTURE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
EXFOLIATIVE RASH
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Vascular disorders
LYMPHOEDEMA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Vascular disorders
SHOCK HAEMORRHAGIC
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Vascular disorders
VENOUS THROMBOSIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
Other adverse events
| Measure |
Phase I, Stage 1: GDC-0032 3 Milligrams (mg) Once
n=6 participants at risk
Participants received GDC-0032 3 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 5 mg QD
n=3 participants at risk
Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 8 mg QD
n=4 participants at risk
Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 12 mg QD
n=10 participants at risk
Participants received GDC- 0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28- day cycles until disease progression.
|
Phase I, Stage 1: GDC-0032 16 mg QD
n=11 participants at risk
Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort A - GDC-0032 9 mg QD
n=20 participants at risk
Participants with PIK3CA-mutant breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort B - GDC-0032 9 mg QD
n=20 participants at risk
Participants with PIK3CA-mutant solid tumors other than breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort C - GDC-0032 9 mg QD + Midazolam 5 mg
n=13 participants at risk
Participants with any type of solid tumors were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD on Days 2 to 29 along with midazolam 5 mg syrup, orally, once on Days 1 and 16 of Cycle 1 (Cycle 1 duration=29 days) followed by GDC-0032 9 mg capsules, orally, QD in subsequent 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort D - GDC-0032 9 mg QD
n=10 participants at risk
Participants with HER2-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 6 mg QD + Letrozole 2.5 mg QD
n=20 participants at risk
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD
n=8 participants at risk
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression
|
Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestran t 500 mg
n=21 participants at risk
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestran t 500 mg
n=6 participants at risk
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD
n=21 participants at risk
Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD
n=35 participants at risk
Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.
|
Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulvestrant 500 mg
n=20 participants at risk
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulvestrant 500 mg
n=20 participants at risk
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulvestrant 500 mg
n=19 participants at risk
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulvestrant 500 mg
n=20 participants at risk
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression
|
Phase I, Stage 2: Cohort N - GDC-0032 2 mg QD + Letrozole 2.5 mg QD
n=27 participants at risk
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression
|
Phase I, Stage 2: Cohort P - GDC-0032 4 mg QD + Letrozole 2.5 mg QD
n=28 participants at risk
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression
|
Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letrozole 2.5 mg QD
n=20 participants at risk
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression
|
Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letrozole 2.5 mg QD
n=20 participants at risk
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression
|
Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letrozole 2.5 mg QD
n=20 participants at risk
Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD
n=10 participants at risk
Participants with non-Hodgkin's lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD
n=10 participants at risk
Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD
n=70 participants at risk
Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.
|
Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
n=122 participants at risk
Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.
|
Phase II: GDC-0032 6 mg QD + Fulvestrant 500 mg
n=60 participants at risk
Postmenopausal participants with locally advanced or metastatic HER2-negative, hormone receptor-positive breast cancer who had not previously received fulvestrant were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycles until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
16.7%
1/6 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
3/21 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
4/28 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.3%
3/70 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.9%
6/122 • Number of events 13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
6.7%
4/60 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Ear and labyrinth disorders
EAR PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
18.2%
2/11 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
8.2%
10/122 • Number of events 18 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
66.7%
2/3 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
36.4%
4/11 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
30.8%
4/13 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
30.0%
3/10 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
2/8 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
28.6%
6/21 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
8.6%
3/35 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.8%
3/19 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
22.2%
6/27 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
17.9%
5/28 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.9%
9/70 • Number of events 11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.0%
11/122 • Number of events 18 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
11.7%
7/60 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
3/21 • Number of events 24 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
40.0%
4/10 • Number of events 10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
30.0%
3/10 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.3%
3/70 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.5%
3/122 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
60.0%
6/10 • Number of events 30 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
6.6%
8/122 • Number of events 14 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Cardiac disorders
ARRHYTHMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK FIRST DEGREE
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Cardiac disorders
BRADYCARDIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
33.3%
1/3 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Cardiac disorders
BUNDLE BRANCH BLOCK LEFT
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Cardiac disorders
LEFT VENTRICULAR FAILURE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Cardiac disorders
MITRAL VALVE INCOMPETENCE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
3/60 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.5%
3/122 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Ear and labyrinth disorders
DEAFNESS UNILATERAL
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
DIARRHOEA
|
16.7%
1/6 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
66.7%
2/3 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
70.0%
7/10 • Number of events 14 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
81.8%
9/11 • Number of events 20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
50.0%
10/20 • Number of events 52 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
80.0%
16/20 • Number of events 31 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
69.2%
9/13 • Number of events 13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
50.0%
5/10 • Number of events 10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
75.0%
15/20 • Number of events 38 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
75.0%
6/8 • Number of events 11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
66.7%
14/21 • Number of events 42 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
66.7%
4/6 • Number of events 25 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
66.7%
14/21 • Number of events 44 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
45.7%
16/35 • Number of events 30 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
55.0%
11/20 • Number of events 85 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
70.0%
14/20 • Number of events 71 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
57.9%
11/19 • Number of events 27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
55.0%
11/20 • Number of events 27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
55.6%
15/27 • Number of events 29 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
71.4%
20/28 • Number of events 82 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
50.0%
10/20 • Number of events 27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
70.0%
14/20 • Number of events 23 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
40.0%
8/20 • Number of events 11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
60.0%
6/10 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
50.0%
5/10 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
47.1%
33/70 • Number of events 73 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
63.1%
77/122 • Number of events 158 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
70.0%
42/60 • Number of events 130 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
3/60 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
3/21 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
21.1%
4/19 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.8%
4/27 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
17.1%
12/70 • Number of events 17 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
13.1%
16/122 • Number of events 18 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
13.3%
8/60 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
33.3%
2/6 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.4%
2/27 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
4/70 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.5%
3/122 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
2/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
WEIGHT DECREASED
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
66.7%
2/3 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
2/8 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
11.4%
4/35 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.4%
2/27 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
4/28 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
14/70 • Number of events 23 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
19.7%
24/122 • Number of events 36 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
6/60 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
23.8%
5/21 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
5/35 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
21.1%
4/19 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.9%
7/27 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
4/28 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
7/70 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.0%
11/122 • Number of events 14 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
13.3%
8/60 • Number of events 11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
HEADACHE
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
40.0%
4/10 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
23.8%
5/21 • Number of events 14 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
30.0%
6/20 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
31.6%
6/19 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.8%
4/27 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
4/28 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
40.0%
8/20 • Number of events 10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
8.6%
6/70 • Number of events 10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
8.2%
10/122 • Number of events 10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
10/60 • Number of events 11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.5%
2/19 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
6.6%
8/122 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
6.7%
4/60 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
11.1%
3/27 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
4/122 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
3/60 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
33.3%
1/3 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
30.0%
3/10 • Number of events 11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
27.3%
3/11 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
40.0%
8/20 • Number of events 15 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.4%
2/13 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
30.0%
3/10 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
37.5%
3/8 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
28.6%
6/21 • Number of events 19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
66.7%
4/6 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
3/21 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
11.4%
4/35 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
18.5%
5/27 • Number of events 10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
4/28 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.9%
9/70 • Number of events 13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.6%
19/122 • Number of events 29 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
15/60 • Number of events 22 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.8%
3/19 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.8%
4/27 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
4/28 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.1%
5/122 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
2/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
16.7%
1/6 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 12 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.4%
2/13 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
28.6%
6/21 • Number of events 10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
19.0%
4/21 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
5/35 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
50.0%
5/10 • Number of events 11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
4/70 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.3%
15/122 • Number of events 17 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
3/60 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Blood and lymphatic system disorders
DISSEMINATED INTRAVASCULAR COAGULATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Ear and labyrinth disorders
HYPOACUSIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Ear and labyrinth disorders
MOTION SICKNESS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Ear and labyrinth disorders
TINNITUS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Ear and labyrinth disorders
EXCESSIVE CERUMEN PRODUCTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Eye disorders
OCULAR HYPERAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Eye disorders
ORBITAL OEDEMA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Eye disorders
PERIORBITAL OEDEMA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Eye disorders
PERIORBITAL SWELLING
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Eye disorders
PHOTOPHOBIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Eye disorders
DIPLOPIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Eye disorders
DRY EYE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.5%
3/122 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
6.7%
4/60 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Eye disorders
EXOPHTHALMOS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Eye disorders
EYE IRRITATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Eye disorders
EYE PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Eye disorders
EYE SWELLING
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Eye disorders
EYELID DISORDER
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Eye disorders
EYELID PTOSIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Eye disorders
GLAUCOMA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Eye disorders
LACRIMATION INCREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
2/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Eye disorders
SCLERAL HAEMORRHAGE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Eye disorders
VISION BLURRED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
3/21 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.1%
5/122 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
2/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Eye disorders
VISUAL IMPAIRMENT
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Eye disorders
VITREOUS FLOATERS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
3/21 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
2/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
33.3%
1/3 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
23.1%
3/13 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
19.0%
4/21 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
33.3%
2/6 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
28.6%
6/21 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
17.1%
6/35 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.8%
3/19 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
18.5%
5/27 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
17.9%
5/28 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
22.9%
16/70 • Number of events 25 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.8%
18/122 • Number of events 30 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
18.3%
11/60 • Number of events 17 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
17.9%
5/28 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
7/70 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
19.0%
4/21 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
33.3%
2/6 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.8%
3/19 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
11.1%
3/27 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
4/70 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.9%
6/122 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
ANAL HAEMORRHAGE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
ABDOMINAL WALL HAEMATOMA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
ANORECTAL DISCOMFORT
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
APHTHOUS ULCER
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
CHAPPED LIPS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
CHEILITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
4/70 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.5%
3/122 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
9/60 • Number of events 11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
CONSTIPATION
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
19.0%
4/21 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
3/21 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
11.4%
4/35 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
30.0%
6/20 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
31.6%
6/19 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
18.5%
5/27 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
4/28 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
10/70 • Number of events 13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.3%
15/122 • Number of events 16 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
6/60 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
DENTAL CARIES
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
DIVERTICULUM INTESTINAL
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.5%
2/19 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
11.1%
3/27 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.3%
3/70 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
6.6%
8/122 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
6/60 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
23.1%
3/13 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
2/8 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.5%
2/19 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
7/122 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
23.3%
14/60 • Number of events 16 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
6.6%
8/122 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
2/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
EPIGASTRIC DISCOMFORT
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
FAECES DISCOLOURED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
ERUCTATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
GLOSSITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.5%
2/19 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.7%
3/28 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
4/122 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
FREQUENT BOWEL MOVEMENTS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Eye disorders
PHOTOPSIA
|
16.7%
1/6 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
21.4%
6/28 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
4/70 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
7/122 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
6/60 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
40.0%
4/10 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
27.3%
3/11 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
45.0%
9/20 • Number of events 11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
2/8 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
23.8%
5/21 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
50.0%
3/6 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
19.0%
4/21 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
7/35 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.8%
3/19 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
22.2%
6/27 • Number of events 12 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
32.1%
9/28 • Number of events 16 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
8.6%
6/70 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
21.3%
26/122 • Number of events 40 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
18.3%
11/60 • Number of events 21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
4/70 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.5%
3/122 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
2/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
GINGIVAL PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
GLOSSODYNIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.7%
3/28 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
HYPERCHLORHYDRIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
HYPOAESTHESIA ORAL
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
LARGE INTESTINAL HAEMORRHAGE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
LIP PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
MESENTERIC ARTERY THROMBOSIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
NAUSEA
|
50.0%
3/6 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
33.3%
1/3 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
90.0%
9/10 • Number of events 12 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
63.6%
7/11 • Number of events 12 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
45.0%
9/20 • Number of events 11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
35.0%
7/20 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
46.2%
6/13 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
60.0%
6/10 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
65.0%
13/20 • Number of events 17 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
62.5%
5/8 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
61.9%
13/21 • Number of events 26 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
100.0%
6/6 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
66.7%
14/21 • Number of events 19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
31.4%
11/35 • Number of events 12 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
35.0%
7/20 • Number of events 16 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
30.0%
6/20 • Number of events 12 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
47.4%
9/19 • Number of events 10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
45.0%
9/20 • Number of events 14 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
59.3%
16/27 • Number of events 21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
60.7%
17/28 • Number of events 25 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
40.0%
8/20 • Number of events 10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
45.0%
9/20 • Number of events 13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
35.0%
7/20 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
34.3%
24/70 • Number of events 33 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
45.1%
55/122 • Number of events 77 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
45.0%
27/60 • Number of events 39 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
ODYNOPHAGIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
33.3%
2/6 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
OESOPHAGEAL PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
ORAL DYSAESTHESIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
ORAL PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.1%
5/122 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
PARAESTHESIA ORAL
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
PERIODONTAL DISEASE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
33.3%
1/3 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
PROCTALGIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
4/122 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
PROCTITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
RECTAL TENESMUS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
RETCHING
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
33.3%
1/3 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
VARICOSE VEINS SUBLINGUAL
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Gastrointestinal disorders
VOMITING
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
66.7%
2/3 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
50.0%
5/10 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
63.6%
7/11 • Number of events 10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
38.5%
5/13 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
45.0%
9/20 • Number of events 12 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
2/8 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
38.1%
8/21 • Number of events 10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
66.7%
4/6 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
23.8%
5/21 • Number of events 11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
11.4%
4/35 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.8%
3/19 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.9%
7/27 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
17.9%
5/28 • Number of events 15 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
27.1%
19/70 • Number of events 24 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
24.6%
30/122 • Number of events 42 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
6/60 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
ASTHENIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
37.5%
3/8 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
28.6%
6/21 • Number of events 11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
33.3%
2/6 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
23.8%
5/21 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.4%
2/27 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.7%
3/28 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
60.0%
6/10 • Number of events 12 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
11.4%
8/70 • Number of events 22 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.8%
12/122 • Number of events 15 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
12/60 • Number of events 18 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
AXILLARY PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.5%
2/19 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.4%
2/27 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
CATHETER SITE ERYTHEMA
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
CATHETER SITE INFLAMMATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
CATHETER SITE OEDEMA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
CATHETER SITE RASH
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
2/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
CHEST PAIN
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
33.3%
1/3 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
6.7%
4/60 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
CHILLS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
66.7%
2/3 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
5/70 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.9%
6/122 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
DEVICE RELATED THROMBOSIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
MUCOSAL INFLAMMATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.4%
2/13 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 15 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
2/8 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
3/21 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
19.0%
4/21 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
11.4%
4/35 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
30.0%
6/20 • Number of events 13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.4%
2/27 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.7%
3/28 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
8.6%
6/70 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
8.2%
10/122 • Number of events 13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
28.3%
17/60 • Number of events 34 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
EARLY SATIETY
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
FATIGUE
|
33.3%
2/6 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
33.3%
1/3 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
50.0%
2/4 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
60.0%
6/10 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
72.7%
8/11 • Number of events 16 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
60.0%
12/20 • Number of events 18 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
76.9%
10/13 • Number of events 13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
50.0%
5/10 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
45.0%
9/20 • Number of events 15 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
2/8 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
42.9%
9/21 • Number of events 20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
28.6%
6/21 • Number of events 12 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.7%
9/35 • Number of events 12 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
40.0%
8/20 • Number of events 18 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
35.0%
7/20 • Number of events 10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
36.8%
7/19 • Number of events 12 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
30.0%
6/20 • Number of events 11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
40.7%
11/27 • Number of events 15 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
28.6%
8/28 • Number of events 18 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
35.0%
7/20 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
40.0%
8/20 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
35.0%
7/20 • Number of events 12 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
35.7%
25/70 • Number of events 40 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
32.8%
40/122 • Number of events 59 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
41.7%
25/60 • Number of events 39 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
GAIT DISTURBANCE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
GENERALISED OEDEMA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
INJECTION SITE PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
6.7%
4/60 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
INJECTION SITE REACTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
2/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
MALAISE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
3/60 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
MULTIPLE ORGAN DYSFUNCTION SYNDROME
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
PYREXIA
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
33.3%
1/3 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
50.0%
5/10 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
27.3%
3/11 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
19.0%
4/21 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
33.3%
2/6 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
3/21 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.5%
2/19 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
11.1%
3/27 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.7%
3/28 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
40.0%
4/10 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
10/70 • Number of events 15 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.8%
18/122 • Number of events 24 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
6/60 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
OEDEMA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
18.2%
2/11 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
23.1%
3/13 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
50.0%
3/6 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
3/21 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
11.4%
4/35 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.5%
2/19 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
10/70 • Number of events 14 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
11.5%
14/122 • Number of events 21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
3/60 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.4%
2/13 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
5/70 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
7/122 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
2/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
PERIPHERAL SWELLING
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
General disorders
XEROSIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Hepatobiliary disorders
HEPATIC PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Immune system disorders
CONTRAST MEDIA ALLERGY
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Immune system disorders
SEASONAL ALLERGY
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
BACTERAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
CANDIDA INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.5%
3/122 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
CATHETER SITE INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
FUNGAL SKIN INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
FURUNCLE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
GASTROINTESTINAL VIRAL INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.3%
3/70 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
2/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
CONJUNCTIVITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.5%
3/122 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
CONJUNCTIVITIS VIRAL
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
CYTOMEGALOVIRUS INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
DIENTAMOEBA INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
ERYTHEMA INDURATUM
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
FUNGAL INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
GINGIVITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
GROIN ABSCESS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.5%
3/122 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Injury, poisoning and procedural complications
ESCHAR
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Injury, poisoning and procedural complications
EYE INJURY
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Injury, poisoning and procedural complications
LIMB FRACTURE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
2/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
HORDEOLUM
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
LARYNGITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
LOCALISED INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
MASTITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
MUCOSAL INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
NAIL INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
PARONYCHIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
PNEUMONIA
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
18.2%
2/11 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
11.4%
4/35 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.3%
3/70 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
PURULENT DISCHARGE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
SINUSITIS
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
3/60 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
TOOTH INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
SKIN CANDIDA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
URINARY TRACT INFECTION BACTERIAL
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
STOMA SITE INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
VARICELLA ZOSTER VIRUS INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
TOOTH ABSCESS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
VAGINAL INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Infections and infestations
VULVOVAGINAL MYCOTIC INFECTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Injury, poisoning and procedural complications
ANIMAL BITE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Injury, poisoning and procedural complications
BURN ORAL CAVITY
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Injury, poisoning and procedural complications
CHEST INJURY
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
BLOOD CHOLESTEROL INCREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
4/122 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Injury, poisoning and procedural complications
SUNBURN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Injury, poisoning and procedural complications
ULNA FRACTURE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
ALANINE AMINOTRANSFERASE ABNORMAL
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
33.3%
1/3 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
18.2%
2/11 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
2/8 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
33.3%
7/21 • Number of events 13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
50.0%
3/6 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
19.0%
4/21 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.5%
2/19 • Number of events 11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.4%
2/27 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
28.6%
8/28 • Number of events 12 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
30.0%
3/10 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.9%
6/122 • Number of events 11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
6.7%
4/60 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
AMYLASE INCREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.4%
2/27 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
3/60 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE ABNORMAL
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
33.3%
1/3 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.4%
2/13 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
2/8 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
38.1%
8/21 • Number of events 13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
50.0%
3/6 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
28.6%
6/21 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.4%
2/27 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
21.4%
6/28 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
6.6%
8/122 • Number of events 12 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
8.3%
5/60 • Number of events 10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
BAND NEUTROPHIL COUNT DECREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
37.5%
3/8 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
23.8%
5/21 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
4/28 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.0%
11/122 • Number of events 19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
4/70 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.5%
3/122 • Number of events 13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
2/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
BLOOD CALCIUM DECREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
BLOOD CHLORIDE DECREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Injury, poisoning and procedural complications
RADIATION SKIN INJURY
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Injury, poisoning and procedural complications
SKIN ABRASION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.4%
2/13 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
40.0%
4/10 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
8.6%
6/70 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.4%
9/122 • Number of events 10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
2/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
FLUID OVERLOAD
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
BLOOD INSULIN INCREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
BLOOD MAGNESIUM DECREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
BLOOD MAGNESIUM INCREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
BLOOD PHOSPHORUS INCREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
BLOOD POTASSIUM DECREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
BLOOD TRIGLYCERIDES INCREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
BLOOD UREA INCREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
ELECTROCARDIOGRAM QT PROLONGED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
INVESTIGATION ABNORMAL
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.9%
6/122 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
2/60 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR INCREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
INTERNATIONAL NORMALISED RATIO INCREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
LIPASE INCREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.4%
2/27 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
4/28 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.9%
6/122 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
LIVER FUNCTION TEST INCREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
LOW DENSITY LIPOPROTEIN INCREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
8.6%
3/35 • Number of events 11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
40.0%
4/10 • Number of events 18 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.5%
3/122 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.5%
3/122 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
STREPTOCOCCUS TEST POSITIVE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
TRANSAMINASES INCREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
TROPONIN INCREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
WEIGHT INCREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
2/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
66.7%
2/3 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
50.0%
2/4 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
60.0%
6/10 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
63.6%
7/11 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
40.0%
8/20 • Number of events 13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
38.5%
5/13 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
35.0%
7/20 • Number of events 12 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
37.5%
3/8 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
47.6%
10/21 • Number of events 17 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
66.7%
4/6 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
28.6%
6/21 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
31.4%
11/35 • Number of events 12 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
40.0%
8/20 • Number of events 13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
21.1%
4/19 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
29.6%
8/27 • Number of events 11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
17.9%
5/28 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
35.0%
7/20 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
40.0%
8/20 • Number of events 14 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
32.9%
23/70 • Number of events 41 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
31.1%
38/122 • Number of events 53 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
31.7%
19/60 • Number of events 30 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
36.4%
4/11 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
23.1%
3/13 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
30.0%
6/20 • Number of events 18 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
19.0%
4/21 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
50.0%
3/6 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
11.4%
4/35 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.4%
2/27 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.7%
3/28 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
7/70 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
11.5%
14/122 • Number of events 23 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
ELECTROLYTE IMBALANCE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
FAILURE TO THRIVE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
50.0%
2/4 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
30.0%
3/10 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
72.7%
8/11 • Number of events 22 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
60.0%
12/20 • Number of events 32 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
23.1%
3/13 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
50.0%
5/10 • Number of events 17 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
45.0%
9/20 • Number of events 21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
50.0%
4/8 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
38.1%
8/21 • Number of events 21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
50.0%
3/6 • Number of events 21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
38.1%
8/21 • Number of events 16 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
17.1%
6/35 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
30.0%
6/20 • Number of events 14 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
30.0%
6/20 • Number of events 10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.9%
7/27 • Number of events 17 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
39.3%
11/28 • Number of events 29 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 12 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
70.0%
7/10 • Number of events 31 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
30.0%
3/10 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
14/70 • Number of events 17 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
35.2%
43/122 • Number of events 96 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
21.7%
13/60 • Number of events 24 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
GLUCOSE TOLERANCE IMPAIRED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
6.7%
4/60 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
HYPERMAGNESAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
HYPERPHOSPHATAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.5%
3/122 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
2/60 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
4/122 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
33.3%
1/3 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
36.4%
4/11 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.4%
2/13 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
35.0%
7/20 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
37.5%
3/8 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
23.8%
5/21 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
66.7%
4/6 • Number of events 13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
23.8%
5/21 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
30.0%
6/20 • Number of events 12 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
11.1%
3/27 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
11.4%
8/70 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
18.9%
23/122 • Number of events 40 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
6/60 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
19.0%
4/21 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
8.6%
3/35 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
7/70 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.8%
12/122 • Number of events 21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
2/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
27.3%
3/11 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
19.0%
4/21 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
19.0%
4/21 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
4/70 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.8%
12/122 • Number of events 22 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
HYPOPHAGIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
LACTIC ACIDOSIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
3/21 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
17.1%
6/35 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
11.4%
8/70 • Number of events 12 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
7/122 • Number of events 16 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
HYPOVOLAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
MALNUTRITION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Metabolism and nutrition disorders
POLYDIPSIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
3/21 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
33.3%
2/6 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
11.4%
4/35 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
42.1%
8/19 • Number of events 11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.9%
7/27 • Number of events 11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
35.7%
10/28 • Number of events 21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
40.0%
8/20 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
35.0%
7/20 • Number of events 10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
5/70 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
7/122 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
23.3%
14/60 • Number of events 16 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
33.3%
1/3 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.5%
2/19 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
6.7%
4/60 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
16.7%
1/6 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.5%
3/122 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
GROIN PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
JOINT RANGE OF MOTION DECREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.5%
3/122 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE DISORDER
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
4/28 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
8.6%
6/70 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
4/122 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
2/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL DISCOMFORT
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.4%
2/27 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
17.9%
5/28 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.3%
3/70 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
7/122 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
2/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
8.3%
5/60 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS OF JAW
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
27.3%
3/11 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.4%
2/13 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
18.5%
5/27 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
8.6%
6/70 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
6.7%
4/60 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN JAW
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
SPINAL PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN NEOPLASM
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BRAIN NEOPLASM
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
16.7%
1/6 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
18.2%
2/11 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
30.0%
3/10 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
37.5%
3/8 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
23.8%
5/21 • Number of events 10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
50.0%
3/6 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
3/21 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
5/35 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
18.5%
5/27 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
5/70 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.4%
9/122 • Number of events 11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
11.7%
7/60 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE TIGHTNESS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
3/21 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.5%
3/122 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.4%
2/27 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HAEMANGIOMA OF SKIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LIP NEOPLASM
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PAPILLOMA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR FISTULISATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
MUSCLE SPASTICITY
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
BALANCE DISORDER
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
CARPAL TUNNEL SYNDROME
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.5%
3/122 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
DYSAESTHESIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
DYSARTHRIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.4%
2/13 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
37.5%
3/8 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
33.3%
2/6 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
8.6%
3/35 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
11.1%
3/27 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.4%
9/122 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
6/60 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
HYPERSOMNIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.4%
2/27 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
8.3%
5/60 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.4%
2/27 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.5%
3/122 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
PAROSMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.4%
2/13 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
8.6%
3/35 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.3%
3/70 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
PRESYNCOPE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
SEIZURE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
SINUS HEADACHE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
TREMOR
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
TASTE DISORDER
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Psychiatric disorders
AGITATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
3/21 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
11.1%
3/27 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.3%
3/70 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.4%
9/122 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
9/60 • Number of events 10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Psychiatric disorders
LIBIDO DECREASED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Psychiatric disorders
MIXED ANXIETY AND DEPRESSIVE DISORDER
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Psychiatric disorders
MOOD ALTERED
|
33.3%
2/6 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Psychiatric disorders
MOOD SWINGS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.3%
3/70 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
4/122 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Renal and urinary disorders
AZOTAEMIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Renal and urinary disorders
BLADDER DISCOMFORT
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Renal and urinary disorders
BLADDER SPASM
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Renal and urinary disorders
CHROMATURIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Renal and urinary disorders
CYSTITIS NONINFECTIVE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Nervous system disorders
NEURALGIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Renal and urinary disorders
MICTURITION URGENCY
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Renal and urinary disorders
URETERIC OBSTRUCTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Renal and urinary disorders
URETERIC STENOSIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Renal and urinary disorders
URINARY HESITATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Renal and urinary disorders
POLLAKIURIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.5%
3/122 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
2/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Renal and urinary disorders
POLYURIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Renal and urinary disorders
PROTEINURIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Reproductive system and breast disorders
BREAST PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
3/60 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Reproductive system and breast disorders
DYSPAREUNIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Renal and urinary disorders
URINARY TRACT PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Reproductive system and breast disorders
BREAST DISCHARGE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Reproductive system and breast disorders
BREAST MASS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Reproductive system and breast disorders
UTERINE PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Reproductive system and breast disorders
VAGINAL DISCHARGE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Reproductive system and breast disorders
VULVAL DISORDER
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Reproductive system and breast disorders
VULVOVAGINAL INFLAMMATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Reproductive system and breast disorders
VULVOVAGINAL BURNING SENSATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Reproductive system and breast disorders
VULVOVAGINAL DRYNESS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
8.3%
5/60 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Reproductive system and breast disorders
VULVOVAGINAL PRURITUS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
33.3%
2/6 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
30.0%
3/10 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
23.1%
3/13 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
28.6%
6/21 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
66.7%
4/6 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
19.0%
4/21 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
8.6%
3/35 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.5%
2/19 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
11.1%
3/27 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
4/28 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
18.6%
13/70 • Number of events 15 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.4%
20/122 • Number of events 23 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
10/60 • Number of events 12 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.5%
3/122 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
30.0%
3/10 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
23.1%
3/13 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
30.0%
3/10 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
19.0%
4/21 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
23.8%
5/21 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
17.1%
6/35 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.4%
2/27 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.7%
3/28 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
10/70 • Number of events 11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.8%
12/122 • Number of events 15 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
13.3%
8/60 • Number of events 10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
INCREASED UPPER AIRWAY SECRETION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Reproductive system and breast disorders
MENOPAUSAL SYMPTOMS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Reproductive system and breast disorders
PENILE HAEMORRHAGE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL INFLAMMATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
LOWER RESPIRATORY TRACT CONGESTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
LUNG CONSOLIDATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
17.9%
5/28 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
8.6%
6/70 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
2/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL DRYNESS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL DISCOMFORT
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.8%
3/19 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
4/28 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
4/122 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
3/60 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
PAINFUL RESPIRATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
PARANASAL SINUS DISCOMFORT
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
PARANASAL SINUS HYPERSECRETION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
4/122 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
5/70 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.9%
6/122 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.3%
3/70 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
2/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
SNEEZING
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESPIRATORY TRACT CONGESTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
BLISTER
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.4%
2/27 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.5%
3/122 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
2/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
COLD SWEAT
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
18.5%
5/27 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
17.9%
5/28 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.5%
3/122 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
11.7%
7/60 • Number of events 8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Respiratory, thoracic and mediastinal disorders
UPPER-AIRWAY COUGH SYNDROME
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
3/60 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
DECUBITUS ULCER
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ALLERGIC
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS EXFOLIATIVE GENERALISED
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
37.5%
3/8 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
3/21 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
33.3%
2/6 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
2/35 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
5/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.5%
2/19 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
17.9%
5/28 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
7/70 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.4%
9/122 • Number of events 11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
26.7%
16/60 • Number of events 18 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
DYSHIDROTIC ECZEMA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.3%
3/70 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
ECZEMA ASTEATOTIC
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
2/10 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
EXFOLIATIVE RASH
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
INGROWING NAIL
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
NAIL DISCOLOURATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
NAIL DISORDER
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
NAIL DYSTROPHY
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
ONYCHOCLASIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.3%
2/60 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
ONYCHOLYSIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
ONYCHOMADESIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.7%
1/27 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
PAPULE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
PHOTOSENSITIVITY REACTION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
30.0%
3/10 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.4%
2/13 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
50.0%
4/8 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
3/21 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
33.3%
2/6 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
19.0%
4/21 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
8.6%
3/35 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.8%
3/19 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
11.1%
3/27 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
4/28 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
8.6%
6/70 • Number of events 10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
13.1%
16/122 • Number of events 23 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
8.3%
5/60 • Number of events 10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
PRURITUS ALLERGIC
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
8.6%
3/35 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
21.1%
4/19 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.4%
2/27 • Number of events 5 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.3%
4/28 • Number of events 10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
5/70 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
14.8%
18/122 • Number of events 26 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
8.3%
5/60 • Number of events 9 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
RASH PAPULAR
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
RASH VESICULAR
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
ROSACEA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
SEBORRHOEIC DERMATITIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.4%
1/70 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
RASH MACULAR
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.6%
2/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
SKIN EXFOLIATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
SKIN FISSURES
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
SKIN HYPERPIGMENTATION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
SKIN PLAQUE
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
SKIN TIGHTNESS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
3.6%
1/28 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
16.7%
1/6 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
1.7%
1/60 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Vascular disorders
EMBOLISM VENOUS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Vascular disorders
FLUSHING
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Vascular disorders
HAEMATOMA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Vascular disorders
HOT FLUSH
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
12.5%
1/8 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.5%
2/21 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
2/20 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.8%
3/19 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
22.2%
6/27 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.1%
2/28 • Number of events 2 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
20.0%
4/20 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
15.0%
3/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.82%
1/122 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
6.7%
4/60 • Number of events 4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
7.7%
1/13 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.7%
4/70 • Number of events 6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.9%
6/122 • Number of events 7 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Vascular disorders
JUGULAR VEIN THROMBOSIS
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/35 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/19 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/70 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
|
Vascular disorders
LYMPHOEDEMA
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/4 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/11 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/13 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/8 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
4.8%
1/21 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/6 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/21 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.3%
1/19 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/27 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/28 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
5.0%
1/20 • Number of events 1 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/20 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/10 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
2.9%
2/70 • Number of events 3 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/122 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
0.00%
0/60 • From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)
The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER