Trial Outcomes & Findings for A Study of GDC-0810 Single Agent or in Combination With Palbociclib and/or a Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer (NCT NCT01823835)
NCT ID: NCT01823835
Last Updated: 2021-06-18
Results Overview
Maximum Tolerated Dose (MTD) is determined based on the number of Dose Limiting Toxicities (DLTs) experienced by the participants. DLTs were defined as any of the following adverse events (AEs) that are deemed by the investigator or the Sponsor to be related to study drug (toxicities will be attributed to single agent GDC-0810 unless they are clearly related to disease progression or can clearly be attributed to a cause other than GDC-0810 administration): * Any grade ≥ 3 non-hematologic toxicity (excluding alopecia) * Any grade ≥ 3 hematologic toxicity of \> 7 days' duration * Any grade toxicity that leads to study drug interruption of \> 7 days' duration
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
152 participants
Primary outcome timeframe
Day -7 through the first cycle (28 days) of treatment (35 days total)
Results posted on
2021-06-18
Participant Flow
Participant milestones
| Measure |
Phase Ia - Cohort 1
100 mg GDC-0810 once daily (QD) in fasting state.
|
Phase Ia - Cohort 2
200 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 3
400 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 4
600 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 5
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
4
|
6
|
6
|
6
|
6
|
3
|
3
|
19
|
10
|
53
|
19
|
4
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
4
|
6
|
6
|
6
|
6
|
3
|
3
|
19
|
10
|
53
|
19
|
4
|
6
|
Reasons for withdrawal
| Measure |
Phase Ia - Cohort 1
100 mg GDC-0810 once daily (QD) in fasting state.
|
Phase Ia - Cohort 2
200 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 3
400 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 4
600 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 5
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Progressive Disease
|
3
|
4
|
3
|
6
|
4
|
6
|
5
|
3
|
3
|
18
|
8
|
46
|
18
|
4
|
6
|
|
Overall Study
Study Termination
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
2
|
1
|
0
|
0
|
Baseline Characteristics
Race/Ethnicity was only collected from 151 participants
Baseline characteristics by cohort
| Measure |
Phase Ia - Cohort 1
n=3 Participants
100 mg GDC-0810 once daily (QD) in fasting state.
|
Phase Ia - Cohort 2
n=4 Participants
200 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 3
n=4 Participants
400 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 4
n=6 Participants
600 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 5
n=6 Participants
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
n=6 Participants
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
n=6 Participants
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
n=3 Participants
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
n=3 Participants
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
n=19 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
n=10 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
n=53 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
n=19 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
n=4 Participants
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
n=6 Participants
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.3 Years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
63.5 Years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
60.8 Years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
55.3 Years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
69.3 Years
STANDARD_DEVIATION 7.2 • n=21 Participants
|
56.2 Years
STANDARD_DEVIATION 12.8 • n=10 Participants
|
50.5 Years
STANDARD_DEVIATION 14.6 • n=115 Participants
|
58.3 Years
STANDARD_DEVIATION 3.5 • n=24 Participants
|
64.7 Years
STANDARD_DEVIATION 4.0 • n=42 Participants
|
55.4 Years
STANDARD_DEVIATION 12.2 • n=42 Participants
|
63.4 Years
STANDARD_DEVIATION 8.9 • n=42 Participants
|
61.9 Years
STANDARD_DEVIATION 9.3 • n=42 Participants
|
62.6 Years
STANDARD_DEVIATION 12.2 • n=36 Participants
|
58.5 Years
STANDARD_DEVIATION 13.1 • n=36 Participants
|
41.7 Years
STANDARD_DEVIATION 8.9 • n=24 Participants
|
59.8 Years
STANDARD_DEVIATION 11.2 • n=135 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
53 Participants
n=42 Participants
|
19 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
6 Participants
n=24 Participants
|
152 Participants
n=135 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=7 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=5 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=4 Participants • Race/Ethnicity was only collected from 151 participants
|
1 Participants
n=21 Participants • Race/Ethnicity was only collected from 151 participants
|
1 Participants
n=10 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=115 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=24 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=42 Participants • Race/Ethnicity was only collected from 151 participants
|
2 Participants
n=42 Participants • Race/Ethnicity was only collected from 151 participants
|
1 Participants
n=42 Participants • Race/Ethnicity was only collected from 151 participants
|
2 Participants
n=42 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=36 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=36 Participants • Race/Ethnicity was only collected from 151 participants
|
3 Participants
n=24 Participants • Race/Ethnicity was only collected from 151 participants
|
10 Participants
n=135 Participants • Race/Ethnicity was only collected from 151 participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=7 Participants • Race/Ethnicity was only collected from 151 participants
|
1 Participants
n=5 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=4 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=21 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=10 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=115 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=24 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=42 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=42 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=42 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=42 Participants • Race/Ethnicity was only collected from 151 participants
|
2 Participants
n=36 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=36 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=24 Participants • Race/Ethnicity was only collected from 151 participants
|
3 Participants
n=135 Participants • Race/Ethnicity was only collected from 151 participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants • Race/Ethnicity was only collected from 151 participants
|
4 Participants
n=7 Participants • Race/Ethnicity was only collected from 151 participants
|
3 Participants
n=5 Participants • Race/Ethnicity was only collected from 151 participants
|
6 Participants
n=4 Participants • Race/Ethnicity was only collected from 151 participants
|
5 Participants
n=21 Participants • Race/Ethnicity was only collected from 151 participants
|
4 Participants
n=10 Participants • Race/Ethnicity was only collected from 151 participants
|
6 Participants
n=115 Participants • Race/Ethnicity was only collected from 151 participants
|
3 Participants
n=24 Participants • Race/Ethnicity was only collected from 151 participants
|
3 Participants
n=42 Participants • Race/Ethnicity was only collected from 151 participants
|
17 Participants
n=42 Participants • Race/Ethnicity was only collected from 151 participants
|
8 Participants
n=42 Participants • Race/Ethnicity was only collected from 151 participants
|
46 Participants
n=42 Participants • Race/Ethnicity was only collected from 151 participants
|
15 Participants
n=36 Participants • Race/Ethnicity was only collected from 151 participants
|
4 Participants
n=36 Participants • Race/Ethnicity was only collected from 151 participants
|
1 Participants
n=24 Participants • Race/Ethnicity was only collected from 151 participants
|
127 Participants
n=135 Participants • Race/Ethnicity was only collected from 151 participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=7 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=5 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=4 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=21 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=10 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=115 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=24 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=42 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=42 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=42 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=42 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=36 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=36 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=24 Participants • Race/Ethnicity was only collected from 151 participants
|
1 Participants
n=135 Participants • Race/Ethnicity was only collected from 151 participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=7 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=5 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=4 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=21 Participants • Race/Ethnicity was only collected from 151 participants
|
1 Participants
n=10 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=115 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=24 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=42 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=42 Participants • Race/Ethnicity was only collected from 151 participants
|
1 Participants
n=42 Participants • Race/Ethnicity was only collected from 151 participants
|
5 Participants
n=42 Participants • Race/Ethnicity was only collected from 151 participants
|
2 Participants
n=36 Participants • Race/Ethnicity was only collected from 151 participants
|
0 Participants
n=36 Participants • Race/Ethnicity was only collected from 151 participants
|
2 Participants
n=24 Participants • Race/Ethnicity was only collected from 151 participants
|
11 Participants
n=135 Participants • Race/Ethnicity was only collected from 151 participants
|
PRIMARY outcome
Timeframe: Day -7 through the first cycle (28 days) of treatment (35 days total)Population: All participants that were enrolled in Phase Ia of the study.
Maximum Tolerated Dose (MTD) is determined based on the number of Dose Limiting Toxicities (DLTs) experienced by the participants. DLTs were defined as any of the following adverse events (AEs) that are deemed by the investigator or the Sponsor to be related to study drug (toxicities will be attributed to single agent GDC-0810 unless they are clearly related to disease progression or can clearly be attributed to a cause other than GDC-0810 administration): * Any grade ≥ 3 non-hematologic toxicity (excluding alopecia) * Any grade ≥ 3 hematologic toxicity of \> 7 days' duration * Any grade toxicity that leads to study drug interruption of \> 7 days' duration
Outcome measures
| Measure |
Phase Ia - All Cohorts
n=41 Participants
GDC-0810 single agent was administered orally on a continuous daily dosing regimen
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ia - Cohort 5
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase Ia: Maximum Tolerated Dose of GDC-0810 When Used as a Single Agent
|
NA milligram (mg)
The MTD could not be determined.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day -7 through the first cycle (28 days) of treatment (35 days total)Population: All participants that were enrolled in Phase Ia of the study.
The recommended Phase II dose (RP2D) was based on the overall safety/tolerability and pharmacokinetic profile of GDC-0810.
Outcome measures
| Measure |
Phase Ia - All Cohorts
n=41 Participants
GDC-0810 single agent was administered orally on a continuous daily dosing regimen
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ia - Cohort 5
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase Ia: RP2D of GDC-0810 When Used as a Single Agent
|
600 milligram (mg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Screening and every 8 weeks from Cycle 1 Day 1 until Cycle 12, thereafter every 3 months until disease progression (up to 3 years)Population: All participants that were enrolled in Phase IIa of the study.
Objective response (OR) is defined as a complete response (CR) or partial response (PR) as determined by investigator assessment according to RECIST v1.1. OR was based on criteria related to changes in size of target lesions. CR was the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Phase Ia - All Cohorts
n=19 Participants
GDC-0810 single agent was administered orally on a continuous daily dosing regimen
|
Phase IIa - Cohort A2
n=10 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
n=53 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
n=19 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ia - Cohort 5
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase IIa: Percentage of Participants With Confirmed Objective Tumor Response of GDC-0810 According to RECIST v1.1
Complete Response
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase IIa: Percentage of Participants With Confirmed Objective Tumor Response of GDC-0810 According to RECIST v1.1
Partial Response
|
0 percentage of participants
|
0 percentage of participants
|
7.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Screening and every 8 weeks from Cycle 1 Day 1 until Cycle 12, thereafter every 3 months until disease progression (up to 3 years)Population: All participants that were enrolled in Phase IIa of the study.
Clinical Benefit Response (CBR) is defined as the percentage of participants achieving confirmed RECIST v1.1 defined CR, PR, and/or stable disease. CR was the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Outcome measures
| Measure |
Phase Ia - All Cohorts
n=19 Participants
GDC-0810 single agent was administered orally on a continuous daily dosing regimen
|
Phase IIa - Cohort A2
n=10 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
n=53 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
n=19 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ia - Cohort 5
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase IIa: Percentage of Participants With Clinical Benefit Response of GDC-0810 According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
|
5.3 percentage of participants
|
10.0 percentage of participants
|
28.3 percentage of participants
|
15.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: first cycle (Days 1 to 28 of a 28-day schedule)Population: All participants that were enrolled in Phase Ib of the study.
The RP2D of GDC-0810 When Used in Combination With Palbociclib and/or LHRH RP2D was not determined since the development of the GDC-0810 was discontinued before enrolling Cohort C2. The RP2D would have been based on the overall safety and PK/PD profile of GDC-0810 and palbociclib, and not necessarily the MTD.
Outcome measures
| Measure |
Phase Ia - All Cohorts
n=4 Participants
GDC-0810 single agent was administered orally on a continuous daily dosing regimen
|
Phase IIa - Cohort A2
n=6 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ia - Cohort 5
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase Ib: RP2D of GDC-0810 When Used in Combination With Palbociclib and/or LHRH
|
NA mg
Due to discontinuation of GDC-0810 development, data is limited and RP2D was not determined
|
NA mg
Due to discontinuation of GDC-0810 development, data is limited and RP2D was not determined
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 3 yearsAn adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Phase Ia - All Cohorts
n=3 Participants
GDC-0810 single agent was administered orally on a continuous daily dosing regimen
|
Phase IIa - Cohort A2
n=4 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
n=4 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
n=6 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ia - Cohort 5
n=6 Participants
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
n=6 Participants
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
n=6 Participants
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
n=3 Participants
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
n=3 Participants
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
n=19 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
n=10 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
n=53 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
n=19 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
n=4 Participants
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
n=6 Participants
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
All Phases: Percentage of Participants With Adverse Events (AEs)
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Single Dose: Day-7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 48 hours postdose; Multiple Doses: Day 29 (Cycle 2 Day 1) at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, hours postdosePopulation: All participants that were enrolled in Phase Ia of the study and provided sufficient blood samples for analysis.
Maximum Plasma Concentration (Cmax) has been calculated using PK samples collected after administration of a single dose (on Day -7) and also following once-daily multiple doses (at steady state on Day 29) of GDC-0810.
Outcome measures
| Measure |
Phase Ia - All Cohorts
n=3 Participants
GDC-0810 single agent was administered orally on a continuous daily dosing regimen
|
Phase IIa - Cohort A2
n=4 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
n=4 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
n=6 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ia - Cohort 5
n=6 Participants
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
n=6 Participants
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
n=6 Participants
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
n=3 Participants
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
n=3 Participants
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase Ia: Maximum Plasma Concentration (Cmax) of GDC-0810 Single Agent and Its Glucuronide Metabolites
GDC-0810-N-Glucuronide (Single Dose)
|
0.0171 micrograms per milliliter (ug/mL)
Standard Deviation 0.021
|
0.0535 micrograms per milliliter (ug/mL)
Standard Deviation 0.015
|
0.177 micrograms per milliliter (ug/mL)
Standard Deviation 0.1
|
0.468 micrograms per milliliter (ug/mL)
Standard Deviation 0.388
|
0.691 micrograms per milliliter (ug/mL)
Standard Deviation 0.526
|
0.299 micrograms per milliliter (ug/mL)
Standard Deviation 0.171
|
1.38 micrograms per milliliter (ug/mL)
Standard Deviation 1.19
|
0.369 micrograms per milliliter (ug/mL)
Standard Deviation 0.338
|
0.153 micrograms per milliliter (ug/mL)
Standard Deviation 0.0421
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ia: Maximum Plasma Concentration (Cmax) of GDC-0810 Single Agent and Its Glucuronide Metabolites
GDC-0810-N-Glucuronide (Multiple Doses)
|
0.067 micrograms per milliliter (ug/mL)
Standard Deviation 0.055
|
0.061 micrograms per milliliter (ug/mL)
Standard Deviation 0.0271
|
0.184 micrograms per milliliter (ug/mL)
Standard Deviation 0.0832
|
0.416 micrograms per milliliter (ug/mL)
Standard Deviation 0.346
|
0.723 micrograms per milliliter (ug/mL)
Standard Deviation 0.338
|
0.181 micrograms per milliliter (ug/mL)
Standard Deviation 0.0846
|
0.74 micrograms per milliliter (ug/mL)
Standard Deviation 0.327
|
1.17 micrograms per milliliter (ug/mL)
Standard Deviation 0.893
|
0.308 micrograms per milliliter (ug/mL)
Standard Deviation 0.148
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ia: Maximum Plasma Concentration (Cmax) of GDC-0810 Single Agent and Its Glucuronide Metabolites
GDC-0810-Acyl-Glucuronide (Single Dose)
|
—
|
—
|
1.46 micrograms per milliliter (ug/mL)
Standard Deviation 0.997
|
3 micrograms per milliliter (ug/mL)
Standard Deviation 0.827
|
2.26 micrograms per milliliter (ug/mL)
Standard Deviation 1.24
|
1.35 micrograms per milliliter (ug/mL)
Standard Deviation 0.876
|
7.02 micrograms per milliliter (ug/mL)
Standard Deviation 8.19
|
1.29 micrograms per milliliter (ug/mL)
Standard Deviation 0.617
|
1.36 micrograms per milliliter (ug/mL)
Standard Deviation 0.421
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ia: Maximum Plasma Concentration (Cmax) of GDC-0810 Single Agent and Its Glucuronide Metabolites
GDC-0810-Acyl-Glucuronide (Multiple Doses)
|
—
|
—
|
1.89 micrograms per milliliter (ug/mL)
Standard Deviation 1.34
|
3.64 micrograms per milliliter (ug/mL)
Standard Deviation 2.96
|
3.16 micrograms per milliliter (ug/mL)
Standard Deviation 1.2
|
0.993 micrograms per milliliter (ug/mL)
Standard Deviation 0.435
|
3.37 micrograms per milliliter (ug/mL)
Standard Deviation 2.34
|
4.62 micrograms per milliliter (ug/mL)
Standard Deviation 2.19
|
2.82 micrograms per milliliter (ug/mL)
Standard Deviation 1.43
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ia: Maximum Plasma Concentration (Cmax) of GDC-0810 Single Agent and Its Glucuronide Metabolites
GDC-0810 (Single Dose)
|
2.29 micrograms per milliliter (ug/mL)
Standard Deviation 1.24
|
3.76 micrograms per milliliter (ug/mL)
Standard Deviation 0.599
|
9.4 micrograms per milliliter (ug/mL)
Standard Deviation 2.53
|
12.7 micrograms per milliliter (ug/mL)
Standard Deviation 5.36
|
22.2 micrograms per milliliter (ug/mL)
Standard Deviation 11.6
|
9.73 micrograms per milliliter (ug/mL)
Standard Deviation 4.5
|
15.9 micrograms per milliliter (ug/mL)
Standard Deviation 3.13
|
15.6 micrograms per milliliter (ug/mL)
Standard Deviation 4.97
|
10.1 micrograms per milliliter (ug/mL)
Standard Deviation 4.23
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ia: Maximum Plasma Concentration (Cmax) of GDC-0810 Single Agent and Its Glucuronide Metabolites
GDC-0810 (Multiple Doses)
|
2.59 micrograms per milliliter (ug/mL)
Standard Deviation 1.43
|
3.26 micrograms per milliliter (ug/mL)
Standard Deviation 1.11
|
9.08 micrograms per milliliter (ug/mL)
Standard Deviation 3.43
|
11.8 micrograms per milliliter (ug/mL)
Standard Deviation 6.61
|
25 micrograms per milliliter (ug/mL)
Standard Deviation 8.35
|
8.89 micrograms per milliliter (ug/mL)
Standard Deviation 3.96
|
18.4 micrograms per milliliter (ug/mL)
Standard Deviation 4.84
|
25.5 micrograms per milliliter (ug/mL)
Standard Deviation 9.3
|
13.9 micrograms per milliliter (ug/mL)
Standard Deviation 4.87
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Single Dose: Day-7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 48 hours postdose; Multiple Doses: Day 29 (Cycle 2 Day 1) at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, hours postdosePopulation: All participants that were enrolled in Phase Ia of the study and provided sufficient blood samples for analysis.
Time to Maximum Concentration (Tmax) has been calculated using PK samples collected after administration of a single dose (on Day -7) and also following once-daily multiple doses (at steady state on Day 29) of GDC-0810.
Outcome measures
| Measure |
Phase Ia - All Cohorts
n=3 Participants
GDC-0810 single agent was administered orally on a continuous daily dosing regimen
|
Phase IIa - Cohort A2
n=4 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
n=4 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
n=6 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ia - Cohort 5
n=6 Participants
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
n=6 Participants
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
n=6 Participants
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
n=3 Participants
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
n=3 Participants
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase Ia: Time to Maximum Concentration (Tmax) of GDC-0810 Single Agent and Its Glucuronide Metabolites
GDC-0810 (Single Dose)
|
1.5 hour (hr)
Interval 1.5 to 2.0
|
1.71 hour (hr)
Interval 1.45 to 2.0
|
2 hour (hr)
Interval 1.0 to 3.0
|
2.99 hour (hr)
Interval 1.25 to 4.0
|
3.01 hour (hr)
Interval 1.5 to 6.0
|
1.48 hour (hr)
Interval 0.217 to 3.03
|
3.04 hour (hr)
Interval 2.17 to 4.0
|
2 hour (hr)
Interval 2.0 to 4.07
|
1.88 hour (hr)
Interval 1.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ia: Time to Maximum Concentration (Tmax) of GDC-0810 Single Agent and Its Glucuronide Metabolites
GDC-0810 (Multiple Doses)
|
1.47 hour (hr)
Interval 0.95 to 2.0
|
0.9 hour (hr)
Interval 0.45 to 1.0
|
1.55 hour (hr)
Interval 1.07 to 1.68
|
2.48 hour (hr)
Interval 1.93 to 6.45
|
2.95 hour (hr)
Interval 1.95 to 4.03
|
1.65 hour (hr)
Interval 0.917 to 3.07
|
1.59 hour (hr)
Interval 1.08 to 1.92
|
2.93 hour (hr)
Interval 1.53 to 6.3
|
2.05 hour (hr)
Interval 1.47 to 2.42
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ia: Time to Maximum Concentration (Tmax) of GDC-0810 Single Agent and Its Glucuronide Metabolites
GDC-0810-N-Glucuronide (Single Dose)
|
0.5 hour (hr)
Interval 0.5 to 1.5
|
1.95 hour (hr)
Interval 1.5 to 2.0
|
2 hour (hr)
Interval 1.52 to 3.0
|
2.85 hour (hr)
Interval 2.0 to 4.0
|
3.51 hour (hr)
Interval 1.5 to 6.07
|
1.72 hour (hr)
Interval 0.217 to 3.03
|
3.54 hour (hr)
Interval 3.0 to 4.0
|
3 hour (hr)
Interval 2.0 to 4.07
|
1.88 hour (hr)
Interval 1.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ia: Time to Maximum Concentration (Tmax) of GDC-0810 Single Agent and Its Glucuronide Metabolites
GDC-0810-N-Glucuronide (Multiple Doses)
|
2 hour (hr)
Interval 0.0 to 2.05
|
1 hour (hr)
Interval 0.9 to 1.48
|
1.64 hour (hr)
Interval 1.52 to 2.08
|
3.49 hour (hr)
Interval 1.93 to 4.45
|
2.95 hour (hr)
Interval 1.95 to 4.03
|
1.65 hour (hr)
Interval 0.917 to 3.07
|
2.27 hour (hr)
Interval 1.08 to 3.03
|
2.93 hour (hr)
Interval 1.53 to 6.3
|
2.05 hour (hr)
Interval 1.47 to 3.37
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ia: Time to Maximum Concentration (Tmax) of GDC-0810 Single Agent and Its Glucuronide Metabolites
GDC-0810-Acyl-Glucuronide (Single Dose)
|
—
|
—
|
2 hour (hr)
Interval 1.52 to 3.0
|
2.85 hour (hr)
Interval 2.72 to 2.98
|
3.51 hour (hr)
Interval 2.0 to 6.07
|
1.98 hour (hr)
Interval 0.717 to 3.03
|
3.54 hour (hr)
Interval 3.0 to 4.0
|
3 hour (hr)
Interval 2.0 to 4.07
|
2.98 hour (hr)
Interval 1.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ia: Time to Maximum Concentration (Tmax) of GDC-0810 Single Agent and Its Glucuronide Metabolites
GDC-0810-Acyl-Glucuronide (Multiple Doses)
|
—
|
—
|
1.84 hour (hr)
Interval 1.52 to 2.17
|
3.53 hour (hr)
Interval 3.07 to 4.0
|
2.95 hour (hr)
Interval 1.95 to 4.03
|
1.65 hour (hr)
Interval 0.917 to 3.07
|
2.27 hour (hr)
Interval 1.08 to 3.03
|
2.93 hour (hr)
Interval 1.53 to 6.3
|
2.05 hour (hr)
Interval 2.0 to 3.37
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Single Dose: Day-7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6 hours postdose; Multiple Doses: Day 29 (Cycle 2 Day 1) at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6 hours postdosePopulation: All participants that were enrolled in Phase Ia of the study and provided sufficient blood samples for analysis.
Area under the concentration-time curves from time 0 to 6 hours (AUC0-6) has been calculated using PK samples collected after administration of a single dose (on Day -7) and also following once-daily multiple doses (at steady state on Day 29) of GDC-0810.
Outcome measures
| Measure |
Phase Ia - All Cohorts
n=3 Participants
GDC-0810 single agent was administered orally on a continuous daily dosing regimen
|
Phase IIa - Cohort A2
n=4 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
n=4 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
n=6 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ia - Cohort 5
n=6 Participants
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
n=6 Participants
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
n=6 Participants
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
n=3 Participants
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
n=3 Participants
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase Ia: Area Under the Concentration-time Curves at 6 Hours (AUC0-6) of GDC-0810 Single Agent and Its Glucuronide Metabolites
GDC-0810 (Multiple Doses)
|
4.83 hr*ug/mL
Standard Deviation 2.3
|
6.19 hr*ug/mL
Standard Deviation 2.18
|
18.8 hr*ug/mL
Standard Deviation 4.76
|
41.1 hr*ug/mL
Standard Deviation 27.5
|
74.9 hr*ug/mL
Standard Deviation 30.1
|
19.3 hr*ug/mL
Standard Deviation 7.01
|
65.7 hr*ug/mL
Standard Deviation 20.6
|
70.5 hr*ug/mL
Standard Deviation 22
|
43 hr*ug/mL
Standard Deviation 26
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ia: Area Under the Concentration-time Curves at 6 Hours (AUC0-6) of GDC-0810 Single Agent and Its Glucuronide Metabolites
GDC-0810 (Single Dose)
|
3.18 hr*ug/mL
Standard Deviation 1.65
|
6.78 hr*ug/mL
Standard Deviation 1.19
|
23.7 hr*ug/mL
Standard Deviation 11.3
|
34.3 hr*ug/mL
Standard Deviation 14.4
|
58.2 hr*ug/mL
Standard Deviation 28.9
|
18.8 hr*ug/mL
Standard Deviation 7.38
|
51.1 hr*ug/mL
Standard Deviation 18
|
48.3 hr*ug/mL
Standard Deviation 28.4
|
22.1 hr*ug/mL
Standard Deviation 5.43
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ia: Area Under the Concentration-time Curves at 6 Hours (AUC0-6) of GDC-0810 Single Agent and Its Glucuronide Metabolites
GDC-0810-N-Glucuronide (Single Dose)
|
0.0401 hr*ug/mL
Standard Deviation 0.0197
|
0.116 hr*ug/mL
Standard Deviation 0.0729
|
0.321 hr*ug/mL
Standard Deviation 0.149
|
1.16 hr*ug/mL
Standard Deviation 0.815
|
1.36 hr*ug/mL
Standard Deviation 0.917
|
0.486 hr*ug/mL
Standard Deviation 0.36
|
3.81 hr*ug/mL
Standard Deviation 4.15
|
0.938 hr*ug/mL
Standard Deviation 0.983
|
0.29 hr*ug/mL
Standard Deviation 0.0295
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ia: Area Under the Concentration-time Curves at 6 Hours (AUC0-6) of GDC-0810 Single Agent and Its Glucuronide Metabolites
GDC-0810-N-Glucuronide (Multiple Doses)
|
0.105 hr*ug/mL
Standard Deviation 0.0724
|
0.103 hr*ug/mL
Standard Deviation 0.0335
|
0.321 hr*ug/mL
Standard Deviation 0.105
|
1.37 hr*ug/mL
Standard Deviation 1.21
|
1.83 hr*ug/mL
Standard Deviation 1.01
|
0.409 hr*ug/mL
Standard Deviation 0.23
|
2.63 hr*ug/mL
Standard Deviation 1.01
|
2.08 hr*ug/mL
Standard Deviation 1.15
|
0.974 hr*ug/mL
Standard Deviation 0.605
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ia: Area Under the Concentration-time Curves at 6 Hours (AUC0-6) of GDC-0810 Single Agent and Its Glucuronide Metabolites
GDC-0810-Acyl-Glucuronide (Single Dose)
|
—
|
—
|
3.18 hr*ug/mL
Standard Deviation 1.77
|
8.25 hr*ug/mL
Standard Deviation 4.54
|
5.29 hr*ug/mL
Standard Deviation 2.71
|
2.76 hr*ug/mL
Standard Deviation 2.23
|
21.1 hr*ug/mL
Standard Deviation 26.9
|
3.99 hr*ug/mL
Standard Deviation 2.29
|
3.27 hr*ug/mL
Standard Deviation 1.03
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ia: Area Under the Concentration-time Curves at 6 Hours (AUC0-6) of GDC-0810 Single Agent and Its Glucuronide Metabolites
GDC-0810-Acyl-Glucuronide (Multiple Doses)
|
—
|
—
|
3.72 hr*ug/mL
Standard Deviation 1.91
|
13 hr*ug/mL
Standard Deviation 11.1
|
8.25 hr*ug/mL
Standard Deviation 3.47
|
2.03 hr*ug/mL
Standard Deviation 0.669
|
14 hr*ug/mL
Standard Deviation 11.1
|
10.2 hr*ug/mL
Standard Deviation 3.61
|
8.45 hr*ug/mL
Standard Deviation 5.79
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Single Dose: Day-7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours postdose; Multiple Doses: Day 29 (Cycle 2 Day 1) at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours postdosePopulation: All participants that were enrolled in Phase Ia of the study and provided sufficient blood samples for analysis.
Area under the concentration-time curves from time 0 to 24 hours (AUC0-24) has been calculated using PK samples collected after administration of a single dose (on Day -7) and also following once-daily multiple doses (at steady state on Day 29) of GDC-0810.
Outcome measures
| Measure |
Phase Ia - All Cohorts
n=3 Participants
GDC-0810 single agent was administered orally on a continuous daily dosing regimen
|
Phase IIa - Cohort A2
n=4 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
n=4 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
n=6 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ia - Cohort 5
n=6 Participants
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
n=6 Participants
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
n=6 Participants
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
n=3 Participants
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
n=3 Participants
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase Ia: Area Under the Concentration-time Curves at 24 Hours (AUC0-24) of GDC-0810 Single Agent and Its Glucuronide Metabolites
GDC-0810 (Single Dose)
|
3.58 hr*ug/mL
Standard Deviation 1.75
|
8.81 hr*ug/mL
Standard Deviation 2.52
|
28.5 hr*ug/mL
Standard Deviation 15.6
|
44.7 hr*ug/mL
Standard Deviation 19.5
|
101 hr*ug/mL
Standard Deviation 49.9
|
41.2 hr*ug/mL
Standard Deviation 15.9
|
61.8 hr*ug/mL
Standard Deviation 25.5
|
95.1 hr*ug/mL
Standard Deviation 76.4
|
47.7 hr*ug/mL
Standard Deviation 11.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ia: Area Under the Concentration-time Curves at 24 Hours (AUC0-24) of GDC-0810 Single Agent and Its Glucuronide Metabolites
GDC-0810 (Multiple Doses)
|
5.34 hr*ug/mL
Standard Deviation 2.99
|
7.36 hr*ug/mL
Standard Deviation 1.32
|
22.8 hr*ug/mL
Standard Deviation 6.14
|
66.9 hr*ug/mL
Standard Deviation 46.8
|
102 hr*ug/mL
Standard Deviation 35.9
|
44.2 hr*ug/mL
Standard Deviation 14.5
|
80.4 hr*ug/mL
Standard Deviation 26.8
|
75.2 hr*ug/mL
Standard Deviation 15.4
|
109 hr*ug/mL
Standard Deviation 73.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ia: Area Under the Concentration-time Curves at 24 Hours (AUC0-24) of GDC-0810 Single Agent and Its Glucuronide Metabolites
GDC-0810-N-Glucuronide (Single Dose)
|
0.13 hr*ug/mL
Standard Deviation 0.0197
|
0.224 hr*ug/mL
Standard Deviation 0.109
|
0.413 hr*ug/mL
Standard Deviation 0.152
|
1.54 hr*ug/mL
Standard Deviation 1.08
|
2.08 hr*ug/mL
Standard Deviation 1.02
|
1.07 hr*ug/mL
Standard Deviation 0.786
|
5.67 hr*ug/mL
Standard Deviation 7.17
|
1.83 hr*ug/mL
Standard Deviation 2.04
|
0.649 hr*ug/mL
Standard Deviation 0.055
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ia: Area Under the Concentration-time Curves at 24 Hours (AUC0-24) of GDC-0810 Single Agent and Its Glucuronide Metabolites
GDC-0810-N-Glucuronide (Multiple Doses)
|
0.13 hr*ug/mL
Standard Deviation 0.0141
|
0.132 hr*ug/mL
Standard Deviation 0.0253
|
0.413 hr*ug/mL
Standard Deviation 0.121
|
2.63 hr*ug/mL
Standard Deviation 2.21
|
2.64 hr*ug/mL
Standard Deviation 1.4
|
1.09 hr*ug/mL
Standard Deviation 0.594
|
3.72 hr*ug/mL
Standard Deviation 1.81
|
2.35 hr*ug/mL
Standard Deviation 1.57
|
2.66 hr*ug/mL
Standard Deviation 1.58
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ia: Area Under the Concentration-time Curves at 24 Hours (AUC0-24) of GDC-0810 Single Agent and Its Glucuronide Metabolites
GDC-0810-Acyl-Glucuronide (Single Dose)
|
—
|
—
|
3.76 hr*ug/mL
Standard Deviation 2.13
|
11.4 hr*ug/mL
Standard Deviation 7.43
|
8.59 hr*ug/mL
Standard Deviation 3.82
|
6.03 hr*ug/mL
Standard Deviation 4.89
|
30.6 hr*ug/mL
Standard Deviation 44
|
7.64 hr*ug/mL
Standard Deviation 5.51
|
7.1 hr*ug/mL
Standard Deviation 1.96
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ia: Area Under the Concentration-time Curves at 24 Hours (AUC0-24) of GDC-0810 Single Agent and Its Glucuronide Metabolites
GDC-0810-Acyl-Glucuronide (Multiple Doses)
|
—
|
—
|
4.42 hr*ug/mL
Standard Deviation 2.27
|
21.8 hr*ug/mL
Standard Deviation 21.2
|
10.4 hr*ug/mL
Standard Deviation 4.07
|
4.61 hr*ug/mL
Standard Deviation 1.34
|
18.1 hr*ug/mL
Standard Deviation 16.3
|
12 hr*ug/mL
Standard Deviation 5.44
|
20.8 hr*ug/mL
Standard Deviation 14.9
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day-7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, and 48 hours postdosePopulation: All participants that were enrolled in Phase Ia of the study, provided sufficient blood samples for analysis and received once daily dosing.
Area under the concentration-time curve from time 0-infinity (AUC0-inf) has been calculated using PK samples collected after administration of a single dose (on Day -7) of GDC-0810.
Outcome measures
| Measure |
Phase Ia - All Cohorts
n=3 Participants
GDC-0810 single agent was administered orally on a continuous daily dosing regimen
|
Phase IIa - Cohort A2
n=4 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
n=4 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
n=5 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ia - Cohort 5
n=6 Participants
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
n=4 Participants
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
n=3 Participants
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-Inf)
|
5.3 hr*ug/ml
Standard Deviation 1.96
|
10 hr*ug/ml
Standard Deviation 2.8
|
30.8 hr*ug/ml
Standard Deviation 16.3
|
40.5 hr*ug/ml
Standard Deviation 11.3
|
114 hr*ug/ml
Standard Deviation 57.4
|
—
|
65.7 hr*ug/ml
Standard Deviation 28
|
101 hr*ug/ml
Standard Deviation 78.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 48 hours postdosePopulation: All participants that were enrolled in Phase Ia of the study and provided sufficient blood samples for analysis.
Half-life (t1/2) was calculated after single dose administration and not at steady state.
Outcome measures
| Measure |
Phase Ia - All Cohorts
n=3 Participants
GDC-0810 single agent was administered orally on a continuous daily dosing regimen
|
Phase IIa - Cohort A2
n=4 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
n=4 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
n=5 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ia - Cohort 5
n=6 Participants
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
n=6 Participants
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
n=4 Participants
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
n=3 Participants
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
n=3 Participants
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase Ia: Plasma Half-life (t1/2) of GDC-0810 Single Agent
|
40.7 hr
Standard Deviation 3.47
|
15.2 hr
Standard Deviation 2.35
|
24.1 hr
Standard Deviation 17.3
|
9.58 hr
Standard Deviation 3.41
|
7.91 hr
Standard Deviation 2.67
|
NA hr
Standard Deviation NA
t1/2 can be estimated only when the PK sample collection following a dose is long enough to characterize the elimination phase. With twice-daily dosing (BID), the PK samples were collected for only up to 6 hours following a dose (after which the patients received their next dose), which is not sufficient to estimate t1/2. Therefore, t1/2 was not reported for BID cohorts.
|
10.1 hr
Standard Deviation 1.59
|
7.09 hr
Standard Deviation 3.23
|
NA hr
Standard Deviation NA
t1/2 can be estimated only when the PK sample collection following a dose is long enough to characterize the elimination phase. With twice-daily dosing (BID), the PK samples were collected for only up to 6 hours following a dose (after which the patients received their next dose), which is not sufficient to estimate t1/2. Therefore, t1/2 was not reported for BID cohorts.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 48 hours postdosePopulation: All participants that were enrolled in Phase Ia of the study and provided sufficient blood samples for analysis.
Apparent Clearance (CL/F) was estimated using PK samples collected following administration of a single dose (on Day -7) of GDC-0810
Outcome measures
| Measure |
Phase Ia - All Cohorts
n=3 Participants
GDC-0810 single agent was administered orally on a continuous daily dosing regimen
|
Phase IIa - Cohort A2
n=4 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
n=4 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
n=5 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ia - Cohort 5
n=6 Participants
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
n=6 Participants
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
n=4 Participants
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
n=3 Participants
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
n=3 Participants
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase Ia: Apparent Clearance (Cl/F)
|
20.4 L/hr
Standard Deviation 6.43
|
21 L/hr
Standard Deviation 4.94
|
15.1 L/hr
Standard Deviation 5.56
|
15.7 L/hr
Standard Deviation 4.13
|
8.21 L/hr
Standard Deviation 8.38
|
NA L/hr
Standard Deviation NA
CL/F can be estimated only when the PK sample collection following a dose is long enough to characterize the elimination phase. With BID dosing, the PK samples were collected for only up to 6 hours before the patient received their next dose, which is not sufficient to estimated CL/F. Therefore, CL/F was not reported for BID cohorts.
|
15.1 L/hr
Standard Deviation 9.45
|
11.1 L/hr
Standard Deviation 6.23
|
NA L/hr
Standard Deviation NA
CL/F can be estimated only when the PK sample collection following a dose is long enough to characterize the elimination phase. With BID dosing, the PK samples were collected for only up to 6 hours before the patient received their next dose, which is not sufficient to estimated CL/F. Therefore, CL/F was not reported for BID cohorts.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening; on Cycle 2 Day 1 predose and at 1, 2, 3, 4, and 6 hours postdose; Cycle 3 Day 1 predose, and at 1, 3, and 6 hours post dosePopulation: All participants enrolled in Phase IIa of the study and with post baseline ECG measurements
The corrected QT interval (QTc) was calculated using Fridericia's formula from electrocardiogram (ECG) data. Changes in ECG intervals from baseline were calculated. Triplicate ECG measurements were collected throughout the study. The averaged triplicate ECG measurements were used for analysis.
Outcome measures
| Measure |
Phase Ia - All Cohorts
n=13 Participants
GDC-0810 single agent was administered orally on a continuous daily dosing regimen
|
Phase IIa - Cohort A2
n=3 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
n=34 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
n=11 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ia - Cohort 5
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase IIa: Effect of GDC-0810 Single Agent on Ventricular Repolarization as Measured by Corrected QT Intervals (QTc) Using Fridericia's Formula
≤ 450 milliseconds (msec)
|
100 percentage of participants
|
66.7 percentage of participants
|
91.2 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase IIa: Effect of GDC-0810 Single Agent on Ventricular Repolarization as Measured by Corrected QT Intervals (QTc) Using Fridericia's Formula
>450 and ≤480 msec
|
0 percentage of participants
|
33.3 percentage of participants
|
8.8 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase IIa: Effect of GDC-0810 Single Agent on Ventricular Repolarization as Measured by Corrected QT Intervals (QTc) Using Fridericia's Formula
Increase from baseline ≤30 msec
|
100 percentage of participants
|
100 percentage of participants
|
93.9 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase IIa: Effect of GDC-0810 Single Agent on Ventricular Repolarization as Measured by Corrected QT Intervals (QTc) Using Fridericia's Formula
Increase from baseline >30 and ≤60 msec
|
0 percentage of participants
|
0 percentage of participants
|
6.1 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: C1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8; D1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1Population: All participants that were enrolled in Phase Ib of the study and provided sufficient samples for analysis.
Cmax has been calculated using PK samples collected after GDC-0810 administration.
Outcome measures
| Measure |
Phase Ia - All Cohorts
n=4 Participants
GDC-0810 single agent was administered orally on a continuous daily dosing regimen
|
Phase IIa - Cohort A2
n=3 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ia - Cohort 5
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase Ib: Cmax of GDC-0810 in Combination With Palbociclib and/or an LHRH Agonist
Cycle 1 Day 1 (C1D1)
|
10.2 ug/ml
Standard Deviation 2.98
|
8.96 ug/ml
Standard Deviation 1.87
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ib: Cmax of GDC-0810 in Combination With Palbociclib and/or an LHRH Agonist
Cycle 1 Day 8 (C1D8)
|
9.95 ug/ml
Standard Deviation 5.85
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ib: Cmax of GDC-0810 in Combination With Palbociclib and/or an LHRH Agonist
Cycle 2 Day 1 (C2D1)
|
—
|
9.62 ug/ml
Standard Deviation 0.0354
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: C1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8; D1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1Population: All participants that were enrolled in Phase Ib of the study and provided sufficient samples for analysis.
Tmax has been calculated using PK samples collected after GDC-0810 administration.
Outcome measures
| Measure |
Phase Ia - All Cohorts
n=4 Participants
GDC-0810 single agent was administered orally on a continuous daily dosing regimen
|
Phase IIa - Cohort A2
n=3 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ia - Cohort 5
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase Ib: Tmax of GDC-0810 in Combination With Palbociclib and/or an LHRH Agonist
C1D1
|
2 hr
Interval 1.0 to 6.0
|
3 hr
Interval 2.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ib: Tmax of GDC-0810 in Combination With Palbociclib and/or an LHRH Agonist
C1D8
|
2.5 hr
Interval 1.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ib: Tmax of GDC-0810 in Combination With Palbociclib and/or an LHRH Agonist
C2D1
|
—
|
3 hr
Interval 3.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: C1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8; D1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1Population: All participants that were enrolled in Phase Ib of the study.
AUC0-6 has been calculated using PK samples collected after GDC-0810 administration.
Outcome measures
| Measure |
Phase Ia - All Cohorts
n=4 Participants
GDC-0810 single agent was administered orally on a continuous daily dosing regimen
|
Phase IIa - Cohort A2
n=3 Participants
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ia - Cohort 5
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase Ib: AUC0-6 of GDC-0810 in Combination With Palbociclib and/or an LHRH Agonist
C1D1
|
18.9 hr*ug/ml
Standard Deviation 9.19
|
33.6 hr*ug/ml
Standard Deviation 7.91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ib: AUC0-6 of GDC-0810 in Combination With Palbociclib and/or an LHRH Agonist
C1D8
|
18.2 hr*ug/ml
Standard Deviation 10.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ib: AUC0-6 of GDC-0810 in Combination With Palbociclib and/or an LHRH Agonist
C2D1
|
—
|
38.8 hr*ug/ml
Standard Deviation 3.53
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: C1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8; D1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1Population: No data from any participants could be used for analysis.
Half-life (t1/2) can be estimated only when the PK sample collection following a dose is long enough to characterize the elimination phase. The PK samples in these cohorts were only collected up to 6 hours following the dose, hence, t1/2 could not be estimated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8Population: All participants that were enrolled in Phase Ib of the study, Cohort C1 and provided sufficient samples for analysis.
Cmax has been calculated using PK samples collected after GDC-0810 administration.
Outcome measures
| Measure |
Phase Ia - All Cohorts
n=4 Participants
GDC-0810 single agent was administered orally on a continuous daily dosing regimen
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ia - Cohort 5
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase Ib: Cmax of Palbociclib in Combination With GDC-0810 and/or an LHRH Agonist
C1D1
|
54.8 ug/ml
Standard Deviation 9.04
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ib: Cmax of Palbociclib in Combination With GDC-0810 and/or an LHRH Agonist
C1D8
|
97.8 ug/ml
Standard Deviation 27.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8Population: All participants that were enrolled in Phase Ib of the study, Cohort C1 and provided sufficient samples for analysis.
Tmax has been calculated using PK samples collected after GDC-0810 administration.
Outcome measures
| Measure |
Phase Ia - All Cohorts
n=4 Participants
GDC-0810 single agent was administered orally on a continuous daily dosing regimen
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ia - Cohort 5
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase Ib: Tmax of Palbociclib in Combination With GDC-0810 and/or an LHRH Agonist
C1D1
|
4 hr
Interval 3.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ib: Tmax of Palbociclib in Combination With GDC-0810 and/or an LHRH Agonist
C1D8
|
6 hr
Interval 0.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8Population: All participants that were enrolled in Phase Ib of the study, Cohort C1 and provided sufficient samples for analysis.
AUC0-6 has been calculated using PK samples collected after GDC-0810 administration.
Outcome measures
| Measure |
Phase Ia - All Cohorts
n=4 Participants
GDC-0810 single agent was administered orally on a continuous daily dosing regimen
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ia - Cohort 5
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase Ib: AUC0-6 of Palbociclib in Combination With GDC-0810 and/or an LHRH Agonist
C1D1
|
200 hr*ug/ml
Standard Deviation 41.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ib: AUC0-6 of Palbociclib in Combination With GDC-0810 and/or an LHRH Agonist
C1D8
|
464 hr*ug/ml
Standard Deviation 106
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort C1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8Population: No data from any participants could be used for analysis.
Half-life (t1/2) can be estimated only when the PK sample collection following a dose is long enough to characterize the elimination phase. The PK samples in these cohorts were only collected up to 6 hours following the dose, hence, t1/2 could not be estimated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1Population: All participants that were enrolled in Phase Ib of the study, Cohort D1 and provided sufficient samples for analysis.
Cmax has been calculated using PK samples collected after GDC-0810 administration.
Outcome measures
| Measure |
Phase Ia - All Cohorts
n=3 Participants
GDC-0810 single agent was administered orally on a continuous daily dosing regimen
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ia - Cohort 5
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase Ib: Cmax of LHRH Agonist in Combination With GDC-0810 and/or Palbociclib
C1D1
|
39.6 ug/ml
Standard Deviation 9.85
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ib: Cmax of LHRH Agonist in Combination With GDC-0810 and/or Palbociclib
C2D1
|
32.4 ug/ml
Standard Deviation NA
The Standard Deviation is not applicable as the results data are reported for 1 participant only.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1Population: All participants that were enrolled in Phase Ib of the study, Cohort D1 and provided sufficient samples for analysis.
Tmax has been calculated using PK samples collected after GDC-0810 administration.
Outcome measures
| Measure |
Phase Ia - All Cohorts
n=3 Participants
GDC-0810 single agent was administered orally on a continuous daily dosing regimen
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ia - Cohort 5
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase Ib: Tmax of LHRH Agonist in Combination With GDC-0810 and/or Palbociclib
C1D1
|
3 hr
Interval 2.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ib: Tmax of LHRH Agonist in Combination With GDC-0810 and/or Palbociclib
C1D8
|
3 hr
The Range is not applicable as the results data are reported for 1 participant only.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1Population: All participants that were enrolled in Phase Ib of the study, Cohort D1 and provided sufficient samples for analysis.
AUC0-6 has been calculated using PK samples collected after GDC-0810 administration.
Outcome measures
| Measure |
Phase Ia - All Cohorts
n=3 Participants
GDC-0810 single agent was administered orally on a continuous daily dosing regimen
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ia - Cohort 5
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase Ib: AUC0-6 of LHRH Agonist in Combination With GDC-0810 and/or an Palbociclib
C1D1
|
118 hr*ug/ml
Standard Deviation 76.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase Ib: AUC0-6 of LHRH Agonist in Combination With GDC-0810 and/or an Palbociclib
C2D1
|
106 hr*ug/ml
Standard Deviation NA
The Standard Deviation is not applicable as the results data are reported for 1 participant only.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort D1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1Population: No data from any participants could be used for analysis.
Half-life (t1/2) can be estimated only when the PK sample collection following a dose is long enough to characterize the elimination phase. The PK samples in these cohorts were only collected up to 6 hours following the dose, hence, t1/2 could not be estimated.
Outcome measures
Outcome data not reported
Adverse Events
Phase Ia - Cohort 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase Ia - Cohort 2
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Phase Ia - Cohort 3
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase Ia - Cohort 4
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase Ia - Cohort 5
Serious events: 3 serious events
Other events: 6 other events
Deaths: 2 deaths
Phase Ia - Cohort 6
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase Ia - Cohort 7
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase Ia - Cohort 8
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase Ia - Cohort 9
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase IIa - Cohort A1
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
Phase IIa - Cohort A2
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Phase IIa - Cohort B1
Serious events: 11 serious events
Other events: 51 other events
Deaths: 3 deaths
Phase IIa - Cohort B2
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Phase Ib - Cohort C1
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase Ib - Cohort D1
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase Ia - Cohort 1
n=3 participants at risk
100 mg GDC-0810 once daily (QD) in fasting state.
|
Phase Ia - Cohort 2
n=4 participants at risk
200 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 3
n=4 participants at risk
400 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 4
n=6 participants at risk
600 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 5
n=6 participants at risk
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
n=6 participants at risk
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
n=6 participants at risk
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
n=3 participants at risk
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
n=3 participants at risk
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
n=19 participants at risk
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
n=10 participants at risk
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
n=53 participants at risk
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
n=19 participants at risk
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
n=4 participants at risk
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
n=6 participants at risk
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/3 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/3 • Up to 3 years
|
25.0%
1/4 • Number of events 2 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
10.5%
2/19 • Number of events 2 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Hepatobiliary disorders
HEPATIC HAEMORRHAGE
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
APPENDICITIS PERFORATED
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
3.8%
2/53 • Number of events 2 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
SEPSIS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
URINARY TRACT INFECTION
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
3.8%
2/53 • Number of events 2 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Nervous system disorders
SEIZURE
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Reproductive system and breast disorders
ENDOMETRIAL HYPERPLASIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 2 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/3 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
General disorders
DISEASE PROGRESSION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
General disorders
FATIGUE
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Injury, poisoning and procedural complications
FRACTURE
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Product Issues
DEVICE DISLOCATION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Vascular disorders
VENOUS THROMBOSIS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
Other adverse events
| Measure |
Phase Ia - Cohort 1
n=3 participants at risk
100 mg GDC-0810 once daily (QD) in fasting state.
|
Phase Ia - Cohort 2
n=4 participants at risk
200 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 3
n=4 participants at risk
400 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 4
n=6 participants at risk
600 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 5
n=6 participants at risk
600 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 6
n=6 participants at risk
300 mg GDC-0810 twice daily (BID) in fasting state.
|
Phase Ia - Cohort 7
n=6 participants at risk
800 mg GDC-0810 QD in fasting state.
|
Phase Ia - Cohort 8
n=3 participants at risk
800 mg GDC-0810 QD in non-fasting state.
|
Phase Ia - Cohort 9
n=3 participants at risk
400 mg GDC-0810 BID in fasting state.
|
Phase IIa - Cohort A1
n=19 participants at risk
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
|
Phase IIa - Cohort A2
n=10 participants at risk
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
|
Phase IIa - Cohort B1
n=53 participants at risk
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
|
Phase IIa - Cohort B2
n=19 participants at risk
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
|
Phase Ib - Cohort C1
n=4 participants at risk
400 mg GDC-0810 + 125 mg Palbociclib QD.
|
Phase Ib - Cohort D1
n=6 participants at risk
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
33.3%
1/3 • Number of events 2 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Injury, poisoning and procedural complications
WOUND
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
AMYLASE INCREASED
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Blood and lymphatic system disorders
ANAEMIA
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
50.0%
2/4 • Number of events 2 • Up to 3 years
|
50.0%
2/4 • Number of events 3 • Up to 3 years
|
50.0%
3/6 • Number of events 3 • Up to 3 years
|
66.7%
4/6 • Number of events 13 • Up to 3 years
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
16.7%
1/6 • Number of events 3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
66.7%
2/3 • Number of events 3 • Up to 3 years
|
10.5%
2/19 • Number of events 2 • Up to 3 years
|
20.0%
2/10 • Number of events 2 • Up to 3 years
|
11.3%
6/53 • Number of events 6 • Up to 3 years
|
21.1%
4/19 • Number of events 8 • Up to 3 years
|
50.0%
2/4 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 3 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
75.0%
3/4 • Number of events 5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
20.0%
2/10 • Number of events 4 • Up to 3 years
|
5.7%
3/53 • Number of events 3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Cardiac disorders
BRADYCARDIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
50.0%
2/4 • Number of events 4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Eye disorders
BLEPHARITIS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Eye disorders
DRY EYE
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Eye disorders
EYELID PTOSIS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Eye disorders
VISION BLURRED
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 2 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
3.8%
2/53 • Number of events 2 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
33.3%
1/3 • Number of events 2 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
50.0%
2/4 • Number of events 3 • Up to 3 years
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
10.5%
2/19 • Number of events 2 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
3.8%
2/53 • Number of events 2 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
66.7%
2/3 • Number of events 2 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
75.0%
3/4 • Number of events 3 • Up to 3 years
|
33.3%
2/6 • Number of events 3 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
15.8%
3/19 • Number of events 3 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
18.9%
10/53 • Number of events 11 • Up to 3 years
|
5.3%
1/19 • Number of events 3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
10.5%
2/19 • Number of events 2 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
11.3%
6/53 • Number of events 11 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
CONSTIPATION
|
66.7%
2/3 • Number of events 2 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
75.0%
3/4 • Number of events 3 • Up to 3 years
|
66.7%
4/6 • Number of events 7 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
33.3%
2/6 • Number of events 5 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
66.7%
2/3 • Number of events 2 • Up to 3 years
|
10.5%
2/19 • Number of events 2 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
30.2%
16/53 • Number of events 21 • Up to 3 years
|
21.1%
4/19 • Number of events 4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
50.0%
3/6 • Number of events 3 • Up to 3 years
|
|
Gastrointestinal disorders
DIARRHOEA
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
25.0%
1/4 • Number of events 2 • Up to 3 years
|
100.0%
4/4 • Number of events 11 • Up to 3 years
|
66.7%
4/6 • Number of events 6 • Up to 3 years
|
100.0%
6/6 • Number of events 22 • Up to 3 years
|
66.7%
4/6 • Number of events 12 • Up to 3 years
|
100.0%
6/6 • Number of events 21 • Up to 3 years
|
100.0%
3/3 • Number of events 7 • Up to 3 years
|
100.0%
3/3 • Number of events 6 • Up to 3 years
|
52.6%
10/19 • Number of events 16 • Up to 3 years
|
50.0%
5/10 • Number of events 11 • Up to 3 years
|
52.8%
28/53 • Number of events 66 • Up to 3 years
|
57.9%
11/19 • Number of events 30 • Up to 3 years
|
50.0%
2/4 • Number of events 2 • Up to 3 years
|
100.0%
6/6 • Number of events 13 • Up to 3 years
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
50.0%
3/6 • Number of events 3 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
26.3%
5/19 • Number of events 5 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
11.3%
6/53 • Number of events 8 • Up to 3 years
|
10.5%
2/19 • Number of events 2 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
DYSPEPSIA
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
33.3%
1/3 • Number of events 2 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
31.6%
6/19 • Number of events 6 • Up to 3 years
|
20.0%
2/10 • Number of events 2 • Up to 3 years
|
11.3%
6/53 • Number of events 6 • Up to 3 years
|
10.5%
2/19 • Number of events 2 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
50.0%
3/6 • Number of events 3 • Up to 3 years
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
5.7%
3/53 • Number of events 3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
ERUCTATION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
3.8%
2/53 • Number of events 2 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
33.3%
2/6 • Number of events 3 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
83.3%
5/6 • Number of events 6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
21.1%
4/19 • Number of events 4 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
24.5%
13/53 • Number of events 14 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
83.3%
5/6 • Number of events 5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 2 • Up to 3 years
|
10.5%
2/19 • Number of events 2 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
17.0%
9/53 • Number of events 10 • Up to 3 years
|
15.8%
3/19 • Number of events 5 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
HAEMORRHOIDAL HAEMORRHAGE
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/3 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
NAUSEA
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
75.0%
3/4 • Number of events 4 • Up to 3 years
|
50.0%
2/4 • Number of events 4 • Up to 3 years
|
100.0%
6/6 • Number of events 11 • Up to 3 years
|
33.3%
2/6 • Number of events 3 • Up to 3 years
|
66.7%
4/6 • Number of events 4 • Up to 3 years
|
100.0%
6/6 • Number of events 15 • Up to 3 years
|
66.7%
2/3 • Number of events 2 • Up to 3 years
|
66.7%
2/3 • Number of events 7 • Up to 3 years
|
42.1%
8/19 • Number of events 9 • Up to 3 years
|
60.0%
6/10 • Number of events 6 • Up to 3 years
|
45.3%
24/53 • Number of events 32 • Up to 3 years
|
47.4%
9/19 • Number of events 10 • Up to 3 years
|
75.0%
3/4 • Number of events 6 • Up to 3 years
|
66.7%
4/6 • Number of events 8 • Up to 3 years
|
|
Gastrointestinal disorders
STOMATITIS
|
66.7%
2/3 • Number of events 2 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
VOMITING
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
50.0%
2/4 • Number of events 3 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
16.7%
1/6 • Number of events 3 • Up to 3 years
|
16.7%
1/6 • Number of events 3 • Up to 3 years
|
66.7%
4/6 • Number of events 15 • Up to 3 years
|
100.0%
3/3 • Number of events 5 • Up to 3 years
|
66.7%
2/3 • Number of events 4 • Up to 3 years
|
36.8%
7/19 • Number of events 11 • Up to 3 years
|
40.0%
4/10 • Number of events 5 • Up to 3 years
|
26.4%
14/53 • Number of events 22 • Up to 3 years
|
10.5%
2/19 • Number of events 2 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
50.0%
3/6 • Number of events 5 • Up to 3 years
|
|
General disorders
ASTHENIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
7.5%
4/53 • Number of events 4 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
General disorders
CHEST PAIN
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
General disorders
CHILLS
|
0.00%
0/3 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
75.0%
3/4 • Number of events 3 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
1.9%
1/53 • Number of events 2 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
|
General disorders
FATIGUE
|
33.3%
1/3 • Number of events 2 • Up to 3 years
|
25.0%
1/4 • Number of events 2 • Up to 3 years
|
75.0%
3/4 • Number of events 3 • Up to 3 years
|
83.3%
5/6 • Number of events 7 • Up to 3 years
|
83.3%
5/6 • Number of events 6 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
100.0%
6/6 • Number of events 12 • Up to 3 years
|
66.7%
2/3 • Number of events 3 • Up to 3 years
|
100.0%
3/3 • Number of events 7 • Up to 3 years
|
42.1%
8/19 • Number of events 9 • Up to 3 years
|
20.0%
2/10 • Number of events 3 • Up to 3 years
|
50.9%
27/53 • Number of events 29 • Up to 3 years
|
36.8%
7/19 • Number of events 7 • Up to 3 years
|
50.0%
2/4 • Number of events 2 • Up to 3 years
|
50.0%
3/6 • Number of events 3 • Up to 3 years
|
|
General disorders
GAIT DISTURBANCE
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
General disorders
IMPAIRED HEALING
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
General disorders
MALAISE
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
General disorders
MUCOSAL INFLAMMATION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
General disorders
OEDEMA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
General disorders
OEDEMA PERIPHERAL
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
50.0%
3/6 • Number of events 3 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
5.7%
3/53 • Number of events 3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
General disorders
PAIN
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
3.8%
2/53 • Number of events 2 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
General disorders
PYREXIA
|
0.00%
0/3 • Up to 3 years
|
50.0%
2/4 • Number of events 2 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
7.5%
4/53 • Number of events 4 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
|
General disorders
SWELLING
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
General disorders
SWELLING FACE
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
General disorders
TENDERNESS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
INFECTION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
LOCALISED INFECTION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
PNEUMONIA
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
5.7%
3/53 • Number of events 3 • Up to 3 years
|
15.8%
3/19 • Number of events 3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
SKIN INFECTION
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
TOOTH INFECTION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
33.3%
2/6 • Number of events 3 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/3 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
15.1%
8/53 • Number of events 9 • Up to 3 years
|
10.5%
2/19 • Number of events 2 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
VAGINAL INFECTION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
5.3%
1/19 • Number of events 2 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
VULVOVAGINAL MYCOTIC INFECTION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 2 • Up to 3 years
|
5.7%
3/53 • Number of events 4 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Injury, poisoning and procedural complications
PELVIC FRACTURE
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
66.7%
2/3 • Number of events 2 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
50.0%
3/6 • Number of events 8 • Up to 3 years
|
50.0%
3/6 • Number of events 5 • Up to 3 years
|
50.0%
3/6 • Number of events 4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
66.7%
2/3 • Number of events 3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
20.0%
2/10 • Number of events 2 • Up to 3 years
|
9.4%
5/53 • Number of events 6 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
66.7%
2/3 • Number of events 2 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
66.7%
4/6 • Number of events 6 • Up to 3 years
|
50.0%
3/6 • Number of events 4 • Up to 3 years
|
66.7%
4/6 • Number of events 7 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
66.7%
2/3 • Number of events 3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
20.0%
2/10 • Number of events 2 • Up to 3 years
|
7.5%
4/53 • Number of events 5 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.00%
0/3 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
50.0%
3/6 • Number of events 4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
1.9%
1/53 • Number of events 3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
BLOOD URIC ACID INCREASED
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.00%
0/3 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Investigations
LIVER FUNCTION TEST INCREASED
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
TRANSAMINASES INCREASED
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
5.7%
3/53 • Number of events 4 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
WEIGHT DECREASED
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
33.3%
2/6 • Number of events 4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
5.7%
3/53 • Number of events 3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
WEIGHT INCREASED
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
50.0%
2/4 • Number of events 3 • Up to 3 years
|
33.3%
2/6 • Number of events 10 • Up to 3 years
|
33.3%
2/6 • Number of events 3 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/3 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
50.0%
2/4 • Number of events 2 • Up to 3 years
|
50.0%
3/6 • Number of events 4 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
66.7%
2/3 • Number of events 6 • Up to 3 years
|
31.6%
6/19 • Number of events 6 • Up to 3 years
|
30.0%
3/10 • Number of events 3 • Up to 3 years
|
17.0%
9/53 • Number of events 9 • Up to 3 years
|
10.5%
2/19 • Number of events 2 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
66.7%
4/6 • Number of events 4 • Up to 3 years
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/3 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
50.0%
2/4 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
2/6 • Number of events 3 • Up to 3 years
|
33.3%
2/6 • Number of events 3 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 2 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
5.7%
3/53 • Number of events 4 • Up to 3 years
|
10.5%
2/19 • Number of events 2 • Up to 3 years
|
50.0%
2/4 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
66.7%
2/3 • Number of events 3 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
50.0%
3/6 • Number of events 5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
66.7%
2/3 • Number of events 2 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
5.7%
3/53 • Number of events 3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.00%
0/3 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 3 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 2 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
33.3%
2/6 • Number of events 4 • Up to 3 years
|
33.3%
2/6 • Number of events 3 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
0.00%
0/3 • Up to 3 years
|
25.0%
1/4 • Number of events 2 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
50.0%
3/6 • Number of events 3 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
20.0%
2/10 • Number of events 3 • Up to 3 years
|
3.8%
2/53 • Number of events 2 • Up to 3 years
|
10.5%
2/19 • Number of events 2 • Up to 3 years
|
50.0%
2/4 • Number of events 2 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
66.7%
4/6 • Number of events 5 • Up to 3 years
|
50.0%
3/6 • Number of events 3 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
33.3%
1/3 • Number of events 3 • Up to 3 years
|
21.1%
4/19 • Number of events 5 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
26.4%
14/53 • Number of events 18 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/3 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
50.0%
2/4 • Number of events 2 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
50.0%
3/6 • Number of events 4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
21.1%
4/19 • Number of events 4 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
24.5%
13/53 • Number of events 15 • Up to 3 years
|
21.1%
4/19 • Number of events 4 • Up to 3 years
|
50.0%
2/4 • Number of events 2 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
5.7%
3/53 • Number of events 3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
50.0%
2/4 • Number of events 2 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
33.3%
2/6 • Number of events 3 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
33.3%
2/6 • Number of events 4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
7.5%
4/53 • Number of events 5 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
10.5%
2/19 • Number of events 2 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 2 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
9.4%
5/53 • Number of events 5 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
13.2%
7/53 • Number of events 7 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
33.3%
2/6 • Number of events 4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
10.5%
2/19 • Number of events 2 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
5.7%
3/53 • Number of events 5 • Up to 3 years
|
10.5%
2/19 • Number of events 2 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
NECK MASS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 3 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
2/6 • Number of events 3 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
5.7%
3/53 • Number of events 3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS OF JAW
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
66.7%
2/3 • Number of events 2 • Up to 3 years
|
21.1%
4/19 • Number of events 4 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
7.5%
4/53 • Number of events 6 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
PAIN IN JAW
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
SPINAL PAIN
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASIS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Nervous system disorders
ATAXIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Nervous system disorders
DIZZINESS
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
1/3 • Number of events 2 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
10.0%
1/10 • Number of events 2 • Up to 3 years
|
3.8%
2/53 • Number of events 2 • Up to 3 years
|
10.5%
2/19 • Number of events 2 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
7.5%
4/53 • Number of events 4 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/3 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
33.3%
2/6 • Number of events 3 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
17.0%
9/53 • Number of events 12 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
33.3%
2/6 • Number of events 3 • Up to 3 years
|
|
Nervous system disorders
HYPERSOMNIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
5.7%
3/53 • Number of events 6 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
5.7%
3/53 • Number of events 3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Nervous system disorders
TASTE DISORDER
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Nervous system disorders
VOCAL CORD PARALYSIS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Psychiatric disorders
ANXIETY
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
5.7%
3/53 • Number of events 3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 2 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
20.0%
2/10 • Number of events 2 • Up to 3 years
|
3.8%
2/53 • Number of events 2 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
10.5%
2/19 • Number of events 2 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
9.4%
5/53 • Number of events 5 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Psychiatric disorders
MOOD SWINGS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
3.8%
2/53 • Number of events 2 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
50.0%
2/4 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
7.5%
4/53 • Number of events 4 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Renal and urinary disorders
MICTURITION URGENCY
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
10.5%
2/19 • Number of events 2 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
7.5%
4/53 • Number of events 4 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Renal and urinary disorders
URINARY TRACT PAIN
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Reproductive system and breast disorders
BREAST ATROPHY
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Reproductive system and breast disorders
BREAST PAIN
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Reproductive system and breast disorders
ENDOMETRIAL THICKENING
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Reproductive system and breast disorders
OEDEMA GENITAL
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Reproductive system and breast disorders
VAGINAL DISCHARGE
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
33.3%
1/3 • Number of events 2 • Up to 3 years
|
47.4%
9/19 • Number of events 9 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
15.1%
8/53 • Number of events 9 • Up to 3 years
|
21.1%
4/19 • Number of events 4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
50.0%
2/4 • Number of events 3 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
66.7%
2/3 • Number of events 2 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
10.5%
2/19 • Number of events 2 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
15.1%
8/53 • Number of events 11 • Up to 3 years
|
26.3%
5/19 • Number of events 6 • Up to 3 years
|
25.0%
1/4 • Number of events 4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
DRY THROAT
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
15.8%
3/19 • Number of events 3 • Up to 3 years
|
20.0%
2/10 • Number of events 2 • Up to 3 years
|
9.4%
5/53 • Number of events 5 • Up to 3 years
|
10.5%
2/19 • Number of events 2 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
50.0%
2/4 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
UPPER-AIRWAY COUGH SYNDROME
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
10.5%
2/19 • Number of events 2 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
3.8%
2/53 • Number of events 2 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
BLISTER
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
1/3 • Number of events 3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
3.8%
2/53 • Number of events 2 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
PAPULE
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
3.8%
2/53 • Number of events 3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/3 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
20.0%
2/10 • Number of events 2 • Up to 3 years
|
5.7%
3/53 • Number of events 3 • Up to 3 years
|
10.5%
2/19 • Number of events 2 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 2 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
3.8%
2/53 • Number of events 2 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Vascular disorders
FLUSHING
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Vascular disorders
HAEMATOMA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Vascular disorders
HOT FLUSH
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
50.0%
3/6 • Number of events 6 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
36.8%
7/19 • Number of events 7 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
18.9%
10/53 • Number of events 11 • Up to 3 years
|
47.4%
9/19 • Number of events 9 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/3 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
2/6 • Number of events 5 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
10.0%
1/10 • Number of events 1 • Up to 3 years
|
3.8%
2/53 • Number of events 2 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Vascular disorders
PALLOR
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
5.3%
1/19 • Number of events 1 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Ear and labyrinth disorders
EAR PAIN
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Ear and labyrinth disorders
EXTERNAL EAR PAIN
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Ear and labyrinth disorders
TINNITUS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Eye disorders
IDIOPATHIC ORBITAL INFLAMMATION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Eye disorders
LACRIMATION INCREASED
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Eye disorders
PHOTOPSIA
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
ASCITES
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
FAECES SOFT
|
0.00%
0/3 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL INFLAMMATION
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
GINGIVAL PAIN
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
GINGIVAL SWELLING
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
LIP SWELLING
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
ORAL MUCOSAL ERUPTION
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
General disorders
FACIAL PAIN
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
BREAST CELLULITIS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
CROUP INFECTIOUS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
EYE INFECTION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
3.8%
2/53 • Number of events 2 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
FUNGAL INFECTION
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
FURUNCLE
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
GASTROENTERITIS NOROVIRUS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
GINGIVITIS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
HELICOBACTER INFECTION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
OTITIS EXTERNA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/3 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
WOUND INFECTION
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Injury, poisoning and procedural complications
MUSCLE STRAIN
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
3.8%
2/53 • Number of events 2 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
BILIRUBIN CONJUGATED INCREASED
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE DECREASED
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
3.8%
2/53 • Number of events 4 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
BLOOD CHLORIDE DECREASED
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
BLOOD CHOLESTEROL INCREASED
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
66.7%
4/6 • Number of events 6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
50.0%
3/6 • Number of events 4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
3.8%
2/53 • Number of events 2 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
BLOOD PHOSPHORUS INCREASED
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
BLOOD THYROID STIMULATING HORMONE INCREASED
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
BLOOD URINE PRESENT
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
CRYSTAL URINE PRESENT
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
GLUCOSE URINE PRESENT
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
HIGH DENSITY LIPOPROTEIN DECREASED
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
HIGH DENSITY LIPOPROTEIN INCREASED
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
LOW DENSITY LIPOPROTEIN INCREASED
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
33.3%
2/6 • Number of events 3 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
50.0%
3/6 • Number of events 5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 4 • Up to 3 years
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
33.3%
2/6 • Number of events 5 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
NEUTROPHIL COUNT INCREASED
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
NITRITE URINE PRESENT
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
RED BLOOD CELL COUNT DECREASED
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
RED BLOOD CELLS URINE POSITIVE
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
URINARY CASTS PRESENT
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/3 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 2 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
3.8%
2/53 • Number of events 2 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
HYPERMAGNESAEMIA
|
33.3%
1/3 • Number of events 3 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
HYPERPROTEINAEMIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
50.0%
3/6 • Number of events 4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
33.3%
2/6 • Number of events 6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
HYPOCHLORAEMIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 3 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
GROIN PAIN
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
JOINT STIFFNESS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Psychiatric disorders
IRRITABILITY
|
33.3%
1/3 • Number of events 2 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Psychiatric disorders
MOOD ALTERED
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Renal and urinary disorders
PROTEINURIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Renal and urinary disorders
RENAL DISORDER
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Renal and urinary disorders
URINARY TRACT DISORDER
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Reproductive system and breast disorders
DYSPAREUNIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Reproductive system and breast disorders
UTERINE POLYP
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
3.8%
2/53 • Number of events 2 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Reproductive system and breast disorders
VULVOVAGINAL DRYNESS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
50.0%
2/4 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
3.8%
2/53 • Number of events 2 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
ACNE
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
1.9%
1/53 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
LICHEN SCLEROSUS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
MACULE
|
0.00%
0/3 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
MADAROSIS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Vascular disorders
LYMPHOEDEMA
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/10 • Up to 3 years
|
0.00%
0/53 • Up to 3 years
|
0.00%
0/19 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
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