Trial Outcomes & Findings for GDC-0449 in Treating Patients With Locally Advanced or Metastatic Solid Tumors (NCT NCT00607724)
NCT ID: NCT00607724
Last Updated: 2015-10-08
Results Overview
A DLT was defined as any Grade 3 or 4 hematologic or major organ toxicity as graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 3.0) that occurred during the first 35 days after the initiation of study drug (Days 1-35) and was attributable to GDC-0449.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
68 participants
Primary outcome timeframe
Up to Week 6
Results posted on
2015-10-08
Participant Flow
Participant milestones
| Measure |
Stage 1: GDC-0449 (150 mg)
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 milligram (mg) on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression (deterioration of evaluable lesions and/or tumor-related symptoms defined using Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST v1.0), maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (270 mg)
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (540 mg)
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma [GDC-0449 (150 mg)]
Participants with basal cell carcinoma (BCC) received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma [GDC-0449 (270 mg)]
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2:Safety Expansion Cohort [GDC-0449 (150 mg)]
Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: New Formulation [GDC-0449 (150 mg )]
Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
|---|---|---|---|---|---|---|---|
|
Stage 1: Dose Escalation
STARTED
|
7
|
9
|
4
|
0
|
0
|
0
|
0
|
|
Stage 1: Dose Escalation
COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1: Dose Escalation
NOT COMPLETED
|
7
|
8
|
4
|
0
|
0
|
0
|
0
|
|
Stage 2: Expanded Cohort
STARTED
|
0
|
0
|
0
|
6
|
14
|
12
|
16
|
|
Stage 2: Expanded Cohort
COMPLETED
|
0
|
0
|
0
|
1
|
5
|
0
|
5
|
|
Stage 2: Expanded Cohort
NOT COMPLETED
|
0
|
0
|
0
|
5
|
9
|
12
|
11
|
Reasons for withdrawal
| Measure |
Stage 1: GDC-0449 (150 mg)
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 milligram (mg) on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression (deterioration of evaluable lesions and/or tumor-related symptoms defined using Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST v1.0), maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (270 mg)
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (540 mg)
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma [GDC-0449 (150 mg)]
Participants with basal cell carcinoma (BCC) received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma [GDC-0449 (270 mg)]
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2:Safety Expansion Cohort [GDC-0449 (150 mg)]
Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: New Formulation [GDC-0449 (150 mg )]
Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
|---|---|---|---|---|---|---|---|
|
Stage 1: Dose Escalation
Tumour Progression-Clinical/Radiographic
|
7
|
8
|
4
|
0
|
0
|
0
|
0
|
|
Stage 2: Expanded Cohort
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Stage 2: Expanded Cohort
Tumour Progression-Clinical/Radiographic
|
0
|
0
|
0
|
4
|
8
|
11
|
10
|
|
Stage 2: Expanded Cohort
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Stage 2: Expanded Cohort
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
GDC-0449 in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Baseline characteristics by cohort
| Measure |
Stage 1: GDC-0449 (150 mg)
n=7 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (270 mg)
n=9 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (540 mg)
n=4 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma [GDC-0449 (150 mg)]
n=6 Participants
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma [GDC-0449 (270 mg)]
n=14 Participants
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2:Safety Expansion Cohort [GDC-0449 (150 mg)]
n=12 Participants
Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: New Formulation [GDC-0449 (150 mg )]
n=16 Participants
Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
59.9 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
42.3 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
54.2 years
STANDARD_DEVIATION 15.3 • n=4 Participants
|
54.7 years
STANDARD_DEVIATION 11.2 • n=21 Participants
|
55.3 years
STANDARD_DEVIATION 14.8 • n=8 Participants
|
54.6 years
STANDARD_DEVIATION 11.0 • n=8 Participants
|
55.0 years
STANDARD_DEVIATION 12.6 • n=24 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
24 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
44 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Up to Week 6Population: Safety-evaluable population.
A DLT was defined as any Grade 3 or 4 hematologic or major organ toxicity as graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 3.0) that occurred during the first 35 days after the initiation of study drug (Days 1-35) and was attributable to GDC-0449.
Outcome measures
| Measure |
Stage 1: GDC-0449 (150 mg)
n=7 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (270 mg)
n=9 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (540 mg)
n=4 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])
n=6 Participants
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])
n=14 Participants
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])
n=12 Participants
Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: New Formulation (GDC-0449 [150 mg])
n=16 Participants
Participants received GDC-0449 Phase II drug product as 150-mg hard gelatin capsules daily, orally, starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Dose-Limiting Toxicities (DLTs)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: -5 minutes (pre-dose) and 0.5, 1, 2, 4, 8, 24 hours post-dose on Day 1; additionally for stage 1 arms: 48 hours (Day 3), 72 hours (Day 4) post-dose and - 5 minutes (pre-dose) on Day 8Population: Pharmacokinetic (PK)-evaluable population included participants who had at least Day 1 PK samples available.
Phase I comprised of two stages, a dose-escalation stage with the goal of estimating the maximum tolerated dose (Stage 1), and an expanded cohort to collect additional safety, PK, and pharmacodynamic (PD) data at the proposed Phase II dose (Stage 2). Phase II represented the additional cohort initiated with 150 mg hard gelatin capsule identified from the safety, PK and PD data from Stage 1 of the trial.
Outcome measures
| Measure |
Stage 1: GDC-0449 (150 mg)
n=7 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (270 mg)
n=9 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (540 mg)
n=4 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])
n=16 Participants
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])
Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: New Formulation (GDC-0449 [150 mg])
Participants received GDC-0449 Phase II drug product as 150-mg hard gelatin capsules daily, orally, starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) After a Single Dose of GDC-0449
Phase I
|
3.58 micromolar (mcM)
Standard Deviation 1.34
|
6.34 micromolar (mcM)
Standard Deviation 3.40
|
6.81 micromolar (mcM)
Standard Deviation 2.69
|
NA micromolar (mcM)
Standard Deviation NA
The arm was only valid for Phase II.
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) After a Single Dose of GDC-0449
Phase II
|
NA micromolar (mcM)
Standard Deviation NA
The arm was only valid for Phase I.
|
NA micromolar (mcM)
Standard Deviation NA
The arm was only valid for Phase I.
|
NA micromolar (mcM)
Standard Deviation NA
The arm was only valid for Phase I.
|
7.2 micromolar (mcM)
Standard Deviation 3.38
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: -5 minutes (pre-dose), 0.5,1,2,4,8 hours post-dose on Day [D] 1; 2,3,4; -5 minutes (pre-dose) on D8,15,22,29,36,64,92,120,148,176,204,232,260,288,316,344;every 4 weeks after D345; end of treatment and study (up to 28 days after last dose), up to 2 yearsPopulation: Cmax was not reported as there were \<50% participants with extensive PK sampling and the PK profiles were flat over 24 hours at steady state which did not allow estimation of Cmax.
Cmax was estimated if there were extensive PK sampling in more that 50% of the participants to form a curve.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: -5 minutes (pre-dose) and 0.5, 1, 2, 4, 8, 24 hours post-dose on Day 1; additionally for stage 1 arms: 48 hours (Day 3), 72 hours (Day 4) post-dose and - 5 minutes (pre-dose) on Day 8Population: PK-evaluable population.
Phase I comprised of two stages, a dose-escalation stage with the goal of estimating the maximum tolerated dose (Stage 1), and an expanded cohort to collect additional safety, PK, and PD data at the proposed Phase II dose (Stage 2). Phase II represented the additional cohort initiated with 150 mg hard gelatin capsule identified from the safety, PK and PD data from Stage 1 of the trial.
Outcome measures
| Measure |
Stage 1: GDC-0449 (150 mg)
n=7 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (270 mg)
n=9 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (540 mg)
n=4 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])
n=16 Participants
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])
Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: New Formulation (GDC-0449 [150 mg])
Participants received GDC-0449 Phase II drug product as 150-mg hard gelatin capsules daily, orally, starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
|---|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) After a Single Dose of GDC-0449
Phase I
|
2 days
Interval 0.0417 to 7.0
|
2 days
Interval 1.0 to 3.0
|
2.5 days
Interval 0.167 to 3.0
|
NA days
The arm was only valid for Phase II.
|
—
|
—
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) After a Single Dose of GDC-0449
Phase II
|
NA days
The arm was only valid for Phase I.
|
NA days
The arm was only valid for Phase I.
|
NA days
The arm was only valid for Phase I.
|
1 days
Interval 0.0833 to 1.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: -5 minutes (pre-dose), 0.5,1,2,4,8 hours post-dose on Day [D] 1; 2,3,4; -5 minutes (pre-dose) on D8,15,22,29,36,64,92,120,148,176,204,232,260,288,316,344;every 4 weeks after D345; end of treatment and study (up to 28 days after last dose), up to 2 yearsPopulation: Cmax was not reported as there were \<50% participants with extensive PK sampling and the PK profiles were flat over 24 hours at steady state which did not allow estimation of Cmax, and as Tmax was related to Cmax, it was also not estimated.
Tmax was estimated if there were extensive PK sampling in more that 50% of the participants to form a curve.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: -5 minutes (pre-dose), 0.5,1,2,4,8 hours post-dose on Day [D] 1; 2,3,4; -5 minutes (pre-dose) on D8,15,22,29,36,64,92,120,148,176,204,232,260,288,316,344;every 4 weeks after D345; end of treatment and study (up to 28 days after last dose), up to 2 yearsPopulation: PK-evaluable population. Here "number of participants analyzed" = participants evaluable for this measure.
Steady state GDC-0449 plasma concentrations (Css) were calculated as an average of plasma concentrations from Study Day 21 (Stage 2) or Study Day 28 (Stage 1) onward.
Outcome measures
| Measure |
Stage 1: GDC-0449 (150 mg)
n=38 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (270 mg)
n=21 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (540 mg)
n=4 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])
n=15 Participants
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])
Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: New Formulation (GDC-0449 [150 mg])
Participants received GDC-0449 Phase II drug product as 150-mg hard gelatin capsules daily, orally, starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
|---|---|---|---|---|---|---|---|
|
Average Plasma Concentration at Steady State (Css, Avg) After Multiple Doses of GDC-0449
|
23.1 mcM
Standard Deviation 10.6
|
19.8 mcM
Standard Deviation 9.51
|
22.2 mcM
Standard Deviation 8.38
|
24.5 mcM
Standard Deviation 6.85
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: -5 minutes (pre-dose) and 0.5, 1, 2, 4, 8, 24 hours post-dose on Day 1; additionally for stage 1 arms: 48 hours (Day 3), 72 hours (Day 4) post-dose and - 5 minutes (pre-dose) on Day 8Population: PK-evaluable population.
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Phase I comprised of two stages, a dose-escalation stage with the goal of estimating the maximum tolerated dose (Stage 1), and an expanded cohort to collect additional safety, PK, and PD data at the proposed Phase II dose (Stage 2). Phase II represented the additional cohort initiated with 150 mg hard gelatin capsule identified from the safety, PK and PD data from Stage 1 of the trial.
Outcome measures
| Measure |
Stage 1: GDC-0449 (150 mg)
n=7 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (270 mg)
n=9 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (540 mg)
n=4 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])
n=16 Participants
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])
Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: New Formulation (GDC-0449 [150 mg])
Participants received GDC-0449 Phase II drug product as 150-mg hard gelatin capsules daily, orally, starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) After a Single Dose of GDC-0449
Phase I
|
2.22 mcM*day
Standard Deviation 0.966
|
4.24 mcM*day
Standard Deviation 1.95
|
4.79 mcM*day
Standard Deviation 2.22
|
NA mcM*day
Standard Deviation NA
The arm was only valid for Phase II.
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) After a Single Dose of GDC-0449
Phase II
|
NA mcM*day
Standard Deviation NA
The arm was only valid for Phase I.
|
NA mcM*day
Standard Deviation NA
The arm was only valid for Phase I.
|
NA mcM*day
Standard Deviation NA
The arm was only valid for Phase I.
|
5.2 mcM*day
Standard Deviation 2.79
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: -5 minutes (pre-dose), 0.5,1,2,4,8 hours post-dose on Day [D] 1; 2,3,4; -5 minutes (pre-dose) on D8,15,22,29,36,64,92,120,148,176,204,232,260,288,316,344;every 4 weeks after D345; end of treatment and study (up to 28 days after last dose), up to 2 yearsPopulation: AUC0-24 was not reported as there were \<50% participants with extensive PK sampling and the PK profiles were flat over 24 hours at steady state which did not allow estimation of AUC0-24.
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUC was estimated if there were extensive PK sampling in more that 50% of the participants to form a curve.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: -5 minutes (pre-dose), 0.5,1,2,4,8 hours post-dose on Day [D] 1; 2,3,4; -5 minutes (pre-dose) on D8,15,22,29,36,64,92,120,148,176,204,232,260,288,316,344;every 4 weeks after D345; end of treatment and study (up to 28 days after last dose), up to 2 yearsPopulation: AI was not reported as there were \<50% participants with extensive PK sampling and the PK profiles were flat over 24 hours at steady state which did not allow estimation of AI.
AI was calculated using the formula \[AI = AUC(0-24) on Day 15/AUC(0-24) on Day 1\]. AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AI was estimated if there were extensive PK sampling in more that 50% of the participants to form a curve.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Day 29Population: Pharmacodynamic-evaluable population included participants who had hair and/or skin samples available from Day 1 and at least one post-baseline sample while on study treatment. Here "number of participants analyzed" = participants evaluable for this measure and "n"= participants evaluable for the specific category.
Ribonucleic acid (RNA) was extracted from biopsy specimens of noninvolved skin or hair follicles at baseline and at 7 and 21 days after the start of daily drug therapy. Control mRNA was obtained from formalin-fixed, paraffin-embedded samples of normal skin and hair follicles from participants who were not enrolled in the study.
Outcome measures
| Measure |
Stage 1: GDC-0449 (150 mg)
n=34 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (270 mg)
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (540 mg)
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])
Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: New Formulation (GDC-0449 [150 mg])
Participants received GDC-0449 Phase II drug product as 150-mg hard gelatin capsules daily, orally, starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Greater Than (>) 2-Fold Down-Modulation of GLI1 Expression in Skin Biopsy-Derived or Hair Follicle-Derived Messenger Ribonucleic Acid (mRNA)
Skin biopsy (n = 34)
|
73.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Greater Than (>) 2-Fold Down-Modulation of GLI1 Expression in Skin Biopsy-Derived or Hair Follicle-Derived Messenger Ribonucleic Acid (mRNA)
Hair follicle (n = 20)
|
30.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening, at Week 8 thereafter every 8 weeks, up to Week 116Population: Efficacy-evaluable population were those with measurable disease at baseline and who received at least 1 dose of GDC-0449 and either had a post-baseline tumor assessment or progressed before any tumor assessment.
BOR was defined as the best objective response (complete or partial response determined by two consecutive investigator assessments which were at least 28 days apart) observed during the treatment period according to RECIST v1.0. CR: disappearance of all target lesions (TLs), with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters (mm). PR: at least a 30 percent (%) decrease in the sum of diameters of TLs, taking as reference the baseline (BL) sum diameters.
Outcome measures
| Measure |
Stage 1: GDC-0449 (150 mg)
n=7 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (270 mg)
n=9 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (540 mg)
n=4 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])
n=6 Participants
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])
n=14 Participants
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])
n=10 Participants
Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: New Formulation (GDC-0449 [150 mg])
n=16 Participants
Participants received GDC-0449 Phase II drug product as 150-mg hard gelatin capsules daily, orally, starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR): All Participants
|
14.3 percentage of participants
|
11.1 percentage of participants
|
0.0 percentage of participants
|
66.7 percentage of participants
|
42.9 percentage of participants
|
0.0 percentage of participants
|
37.5 percentage of participants
|
SECONDARY outcome
Timeframe: Screening, at Week 8 thereafter every 8 weeks, up to Week 116Population: Efficacy-evaluable population; only participants with BCC were included in the analysis.
BOR was defined as the best objective response observed during the treatment period according to RECIST v1.0. CR: disappearance of all TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters.
Outcome measures
| Measure |
Stage 1: GDC-0449 (150 mg)
n=1 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (270 mg)
n=1 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (540 mg)
n=1 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])
n=6 Participants
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])
n=14 Participants
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])
n=10 Participants
Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: New Formulation (GDC-0449 [150 mg])
Participants received GDC-0449 Phase II drug product as 150-mg hard gelatin capsules daily, orally, starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a BOR of CR or PR: Participants With Basal Cell Carcinoma
|
100.0 percentage of participants
|
100.0 percentage of participants
|
0.0 percentage of participants
|
66.7 percentage of participants
|
42.9 percentage of participants
|
60.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Screening, at Week 8 thereafter every 8 weeks, up to Week 116Population: Efficacy-evaluable population; only participants who achieved a best overall response of CR or PR were included in the analysis.
Duration of response during first line therapy is defined as the time from when response (CR or PR) was first documented to first documented disease progression or death (whichever occurs first) during first line therapy. This was only calculated for participants who achieved a best overall response of CR or PR. Participants who did not progress or die after they had a confirmed response were censored at the date of their last tumor measurement or last follow-up for progression of disease during first line therapy.
Outcome measures
| Measure |
Stage 1: GDC-0449 (150 mg)
n=1 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (270 mg)
n=1 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (540 mg)
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])
n=4 Participants
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])
n=6 Participants
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])
Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: New Formulation (GDC-0449 [150 mg])
n=6 Participants
Participants received GDC-0449 Phase II drug product as 150-mg hard gelatin capsules daily, orally, starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
|---|---|---|---|---|---|---|---|
|
Duration of Objective Response: All Participants
|
9.2 months
Upper and lower limits of 95% CI could not be estimated as n=1.
|
NA months
Median duration of response could not be estimated as median duration of response had not been reached at the time of analysis.
|
—
|
6.1 months
Interval 3.71 to
Upper limit of CI could not be estimated due to consequence regarding occurrence of events and their censoring.
|
NA months
Interval 5.72 to
Median duration of response could not be estimated as median duration of response had not been reached at the time of analysis.
|
—
|
8.3 months
Interval 3.71 to
Upper limit of CI could not be estimated due to consequence regarding occurrence of events and their censoring.
|
SECONDARY outcome
Timeframe: Screening, at Week 8 thereafter every 8 weeks, up to Week 116Population: Efficacy-evaluable participants; only participants with BCC who achieved a best overall response of CR or PR were included in the analysis.
Duration of response during first line therapy is defined as the time from when response (CR or PR) was first documented to first documented disease progression or death (whichever occurs first) during first line therapy. This was only calculated for participants who achieved a best overall response of CR or PR. Participants who did not progress or die after they had a confirmed response were censored at the date of their last tumor measurement or last follow-up for progression of disease during first line therapy.
Outcome measures
| Measure |
Stage 1: GDC-0449 (150 mg)
n=11 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (270 mg)
n=7 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (540 mg)
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])
Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: New Formulation (GDC-0449 [150 mg])
Participants received GDC-0449 Phase II drug product as 150-mg hard gelatin capsules daily, orally, starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
|---|---|---|---|---|---|---|---|
|
Duration of Objective Response: Participants With BCC
|
8.3 months
Interval 3.71 to
Upper limit of CI could not be estimated due to consequence regarding occurrence of events and their censoring.
|
NA months
Interval 5.72 to
Median duration of response could not be estimated as median duration of response had not been reached at the time of analysis.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening, at Week 8 thereafter every 8 weeks, up to Week 116Population: Efficacy-evaluable population. Number of participants censored for Stage 1 150 mg, 270 mg, and 540 mg were 1, 2, and 1 subjects, respectively and for Stage 2 BCC 150 mg, 270 mg, Stage 2 Safety Expansion Cohort 150 mg, and Stage 2 New Formulation 150 mg were 2, 6, 1, and 6 subjects, respectively.
PFS was defined as the time from first dose of GDC-0449 to documented disease progression (deterioration of evaluable lesions and/or tumor-related symptoms defined using RECIST v1.0) or death from any cause within 30 days of the last dose of GDC-0449, whichever occurred first.
Outcome measures
| Measure |
Stage 1: GDC-0449 (150 mg)
n=7 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (270 mg)
n=9 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (540 mg)
n=4 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])
n=6 Participants
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])
n=14 Participants
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])
n=10 Participants
Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: New Formulation (GDC-0449 [150 mg])
n=16 Participants
Participants received GDC-0449 Phase II drug product as 150-mg hard gelatin capsules daily, orally, starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
|---|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS): All Participants
|
2.0 months
Interval 0.99 to 14.85
|
1.6 months
Interval 0.85 to 5.88
|
2.1 months
Interval 1.25 to 3.02
|
9.6 months
Interval 5.75 to
Upper limit of CI could not be estimated due to consequence regarding occurrence of events and their censoring.
|
12.7 months
Interval 6.7 to
Upper limit of CI could not be estimated due to consequence regarding occurrence of events and their censoring.
|
1.8 months
Interval 0.76 to 2.1
|
7.1 months
Interval 0.99 to
Upper limit of CI could not be estimated due to consequence regarding occurrence of events and their censoring.
|
SECONDARY outcome
Timeframe: Screening, at Week 8 thereafter every 8 weeks, up to Week 116Population: Efficacy-evaluable population; only participants with BCC were included in the analysis. Number of participants censored for Stage 1+Stage 2 150 mg, and Stage 1+Stage 2 270 mg were 8 and 7 subjects, respectively, and no subject censored from Stage 1 540 mg group.
PFS was defined as the time from first dose of GDC-0449 to documented disease progression (deterioration of evaluable lesions and/or tumor-related symptoms defined using RECIST v1.0) or death from any cause within 30 days of the last dose of GDC-0449, whichever occurred first.
Outcome measures
| Measure |
Stage 1: GDC-0449 (150 mg)
n=17 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (270 mg)
n=15 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (540 mg)
n=1 Participants
Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])
Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])
Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
Stage 2: New Formulation (GDC-0449 [150 mg])
Participants received GDC-0449 Phase II drug product as 150-mg hard gelatin capsules daily, orally, starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
|---|---|---|---|---|---|---|---|
|
PFS: Participants With BCC
|
10.8 months
Interval 6.67 to
Upper limit of CI could not be estimated due to consequence regarding occurrence of events and their censoring.
|
12.7 months
Interval 6.7 to
Upper limit of CI could not be estimated due to consequence regarding occurrence of events and their censoring.
|
1.2 months
Upper and lower limits of 95% CI could not be estimated as n=1.
|
—
|
—
|
—
|
—
|
Adverse Events
Stage 1: GDC-0449 (150 mg)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Stage 1: GDC-0449 (270 mg)
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Stage 1: GDC-0449 (540 mg)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Stage 2: Basal Cell Carcinoma [GDC-0449 (150 mg)]
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Stage 2: Basal Cell Carcinoma [GDC-0449 (270 mg)]
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
Stage 2:Safety Expansion Cohort [GDC-0449 (150 mg)]
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Stage 2: New Formulation [GDC-0449 (150 mg )]
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage 1: GDC-0449 (150 mg)
n=7 participants at risk
Participants received single dose of GDC-0449 hard gelatin capsules at 150 mg on Day 1, thereafter Day 8 received daily until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (270 mg)
n=9 participants at risk
Stage 1: GDC-0449 (270 mg) Participants received single dose of GDC-0449 hard gelatin capsules at 270 mg on Day 1, thereafter Day 8 received daily dose until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (540 mg)
n=4 participants at risk
Participants received single dose of GDC-0449 hard gelatin capsules at 540 mg on Day 1, thereafter Day 8 received daily dose until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma [GDC-0449 (150 mg)]
n=6 participants at risk
Participants with basal cell carcinoma (BCC) received daily dose of GDC-0449 hard gelatin capsules at 150 mg on Day 1 until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma [GDC-0449 (270 mg)]
n=14 participants at risk
Participants with basal cell carcinoma (BCC) received daily dose of GDC-0449 hard gelatin capsules at 270 mg on Day 1 until disease progression, maximum benefit, or intolerability.
|
Stage 2:Safety Expansion Cohort [GDC-0449 (150 mg)]
n=12 participants at risk
Participants with tolerable safety, pharmacokinetic and pharmacodynamic data from Stage 1 received daily dose of GDC-0449 hard gelatin capsules at 150 mg on Day 1 until disease progression, maximum benefit, or intolerability.
|
Stage 2: New Formulation [GDC-0449 (150 mg )]
n=16 participants at risk
Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
2/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
General disorders
Pain
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Infection
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chondrosarcoma
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
Other adverse events
| Measure |
Stage 1: GDC-0449 (150 mg)
n=7 participants at risk
Participants received single dose of GDC-0449 hard gelatin capsules at 150 mg on Day 1, thereafter Day 8 received daily until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (270 mg)
n=9 participants at risk
Stage 1: GDC-0449 (270 mg) Participants received single dose of GDC-0449 hard gelatin capsules at 270 mg on Day 1, thereafter Day 8 received daily dose until disease progression, maximum benefit, or intolerability.
|
Stage 1: GDC-0449 (540 mg)
n=4 participants at risk
Participants received single dose of GDC-0449 hard gelatin capsules at 540 mg on Day 1, thereafter Day 8 received daily dose until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma [GDC-0449 (150 mg)]
n=6 participants at risk
Participants with basal cell carcinoma (BCC) received daily dose of GDC-0449 hard gelatin capsules at 150 mg on Day 1 until disease progression, maximum benefit, or intolerability.
|
Stage 2: Basal Cell Carcinoma [GDC-0449 (270 mg)]
n=14 participants at risk
Participants with basal cell carcinoma (BCC) received daily dose of GDC-0449 hard gelatin capsules at 270 mg on Day 1 until disease progression, maximum benefit, or intolerability.
|
Stage 2:Safety Expansion Cohort [GDC-0449 (150 mg)]
n=12 participants at risk
Participants with tolerable safety, pharmacokinetic and pharmacodynamic data from Stage 1 received daily dose of GDC-0449 hard gelatin capsules at 150 mg on Day 1 until disease progression, maximum benefit, or intolerability.
|
Stage 2: New Formulation [GDC-0449 (150 mg )]
n=16 participants at risk
Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
55.6%
5/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
33.3%
2/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
35.7%
5/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
33.3%
4/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
31.2%
5/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
22.2%
2/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
50.0%
3/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
28.6%
4/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
37.5%
6/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
50.0%
3/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
14.3%
2/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
2/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
12.5%
2/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
22.2%
2/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
14.3%
2/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
3/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
12.5%
2/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
22.2%
2/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
3/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
12.5%
2/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
21.4%
3/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
18.8%
3/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
22.2%
2/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
21.4%
3/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
2/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
28.6%
4/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
12.5%
2/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Dysphagia
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
21.4%
3/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Dry mouth
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
33.3%
2/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
12.5%
2/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
12.5%
2/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
22.2%
2/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Ascites
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
14.3%
2/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Dyschezia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Mucous stools
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Oral cavity fistula
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
28.6%
2/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
22.2%
2/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
66.7%
4/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
85.7%
12/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
68.8%
11/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
22.2%
2/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
33.3%
2/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
2/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
4/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
21.4%
3/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
12.5%
2/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
12.5%
2/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
33.3%
3/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
14.3%
2/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
12.5%
2/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
33.3%
3/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
33.3%
2/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
12.5%
2/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
22.2%
2/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
14.3%
2/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
14.3%
2/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
14.3%
2/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
General disorders
Fatigue
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
44.4%
4/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
66.7%
4/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
57.1%
8/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
50.0%
6/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
31.2%
5/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
General disorders
Pyrexia
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
21.4%
3/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
2/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
General disorders
Pain
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
21.4%
3/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
12.5%
2/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
General disorders
Chest pain
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
21.4%
3/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
12.5%
2/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
General disorders
Oedema peripheral
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
18.8%
3/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
General disorders
Oedema
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
General disorders
Chest discomfort
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
22.2%
2/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
14.3%
2/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
General disorders
Chills
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
21.4%
3/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
General disorders
Facial pain
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
14.3%
2/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
General disorders
Influenza like illness
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
14.3%
2/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
General disorders
Gait disturbance
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
General disorders
Asthenia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
General disorders
Axillary pain
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
General disorders
Catheter site pain
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
General disorders
Catheter site related reaction
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
General disorders
Feeling cold
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
General disorders
Feeling hot
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
General disorders
Feeling jittery
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
General disorders
Puncture site haemorrhage
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
General disorders
Sensation of foreign body
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
General disorders
Unevaluable event
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Dysgeusia
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
33.3%
3/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
83.3%
5/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
57.1%
8/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
2/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
50.0%
8/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
75.0%
3/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
12.5%
2/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
14.3%
2/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
14.3%
2/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
14.3%
2/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
14.3%
2/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Somnolence
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Ageusia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
12.5%
2/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Anosmia
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Tremor
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Amimia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Cognitive disorder
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Paresis cranial nerve
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Parosmia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Phantom pain
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Tongue paralysis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Nervous system disorders
Viith nerve paralysis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
50.0%
3/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
71.4%
10/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
56.2%
9/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
22.2%
2/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
33.3%
2/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
12.5%
2/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
28.6%
4/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
33.3%
2/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
12.5%
2/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
21.4%
3/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
22.2%
2/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Madarosis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Actinic elastosis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Campbell de morgan spots
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
hair colour changes
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Skin tightness
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
44.4%
4/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
50.0%
2/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
28.6%
4/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
41.7%
5/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
18.8%
3/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
42.9%
3/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
33.3%
2/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
14.3%
2/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
14.3%
2/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
2/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
18.8%
3/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
33.3%
2/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
14.3%
2/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
12.5%
2/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
33.3%
2/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
33.3%
2/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Metabolism and nutrition disorders
Salt craving
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
22.2%
2/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
33.3%
2/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
35.7%
5/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
2/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
12.5%
2/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
28.6%
2/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
33.3%
2/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
14.3%
2/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
3/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
18.8%
3/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
33.3%
2/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
2/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
14.3%
2/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
14.3%
2/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
33.3%
2/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal swelling
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory tract congestion
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
21.4%
3/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
2/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
12.5%
2/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
21.4%
3/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
12.5%
2/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Influenza
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
14.3%
2/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
33.3%
2/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
14.3%
2/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Eye infection
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Folliculitis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
14.3%
2/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Wound infection
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
14.3%
2/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Abscess limb
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Candidiasis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Cystitis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Infected cyst
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Localised infection
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Oral herpes
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Rash pustular
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Skin infection
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Investigations
Weight decreased
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
33.3%
3/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
33.3%
2/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
28.6%
4/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
2/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
37.5%
6/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Investigations
Blood chloride decreased
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Investigations
Blood urea increased
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Investigations
Weight increased
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Investigations
Blood bilirubin increased
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Investigations
Blood potassium increased
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Investigations
Blood urine
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Investigations
Blood urine present
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Investigations
Carbohydrate antigen 19-9 increased
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Investigations
Electrocardiogram change
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Investigations
Metamyelocyte percentage increased
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Investigations
Myelocyte percentage increased
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
22.2%
2/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
4/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
21.4%
3/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
4/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Psychiatric disorders
Depression
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Psychiatric disorders
Stress
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Vascular disorders
Flushing
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
21.4%
3/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
2/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
12.5%
2/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Vascular disorders
Deep vein thrombosis
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Vascular disorders
Hot flush
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Eye disorders
Vision blurred
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
12.5%
2/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Eye disorders
Arcus lipoides
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Eye disorders
Dry eye
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Eye disorders
Eye discharge
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Eye disorders
Keratitis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Eye disorders
Photophobia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Eye disorders
Photopsia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Eye disorders
Pterygium
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
50.0%
2/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
33.3%
2/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
22.2%
2/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
14.3%
2/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
14.3%
2/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
33.3%
2/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Ear and labyrinth disorders
Auricular swelling
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Ear and labyrinth disorders
Dysacusis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Ear and labyrinth disorders
Ear canal stenosis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
25.0%
1/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Cardiac disorders
Cardiac flutter
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
16.7%
1/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
14.3%
1/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin neoplasm bleeding
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
6.2%
1/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
8.3%
1/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Reproductive system and breast disorders
Breast swelling
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
11.1%
1/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/7 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/9 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/4 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/6 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
7.1%
1/14 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/12 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
0.00%
0/16 • From Screening up to 28 days after the last dose of GDC-0449 (Week 116).
|
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