Trial Outcomes & Findings for Study For Patients With NSCLC EGFR Mutations (Del 19 or L858R +/- T790M) (NCT NCT02349633)
NCT ID: NCT02349633
Last Updated: 2021-06-10
Results Overview
DLT was defined as any of the following adverse events (AEs) occurring during the first cycle for Phase 1 dose-escalation cohorts, Japan LIC and Phase 1b Cohort 3, or the first 2 cycles for Phase 1b Cohort 2A of treatment, and considered attributable to study intervention: Grade 4 neutropenia \>7 days; febrile neutropenia; Grade \>=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia; Grade \>=3 non-hematologic toxicities; Grade 4 rash, mucositis, or diarrhea; failure to receive at least 70% of planned doses; Grade 3 QTcF prolongation in asymptomatic participants; treatment-related AEs attributable to PF-06747775, palbociclib or both that caused palbociclib treatment delay \>= 10 days or omission of at least 12 doses of the combination. Grade of AE was defined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
65 participants
Primary outcome timeframe
21 days for Phase 1 dose-escalation cohorts and Japan LIC; 42 days for Phase 1b Cohort 2A; 28 days for Phase 1b Cohort 3
Results posted on
2021-06-10
Participant Flow
A total of 65 participants were enrolled, assigned to study treatment and treated in the study. The study was prematurely terminated by sponsor due to an internal strategic decision and changes in the external environment. No safety concerns were related to the study termination. No enrollments occurred in Phase 1 Food Effect and Rifampin Drug-Drug Interaction (DDI) sub-study, Phase 2 Cohort 2B or Phase 1b Cohort 3 prior to study termination.
Participant milestones
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
PF-06747775 200 mg QD Group
Participants received a single oral dose of PF-06747775 200 mg on Day -4 in lead-in period, followed by continuous oral dosing of PF-06747775 200 mg QD for 21-day cycles (up to a maximum of 165 weeks). PF-06747775 200 mg QD group was a combined group of PF-06747775 200 mg QD + sildenafil 25 mg SD (Phase 1 Sildenafil sub-study), PF-06747775 200 mg QD + esomeprazole/itraconazole (Phase 1 Esomeprazole/Itraconazole sub-study), Japan Lead-in cohort (LIC) and Phase 2 Cohort 1.
|
Phase 1 Sildenafil Sub-study: PF-06747775 300 mg QD + Sildenafil 25 mg SD
Participants received a single oral dose of sildenafil 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 121 weeks) plus a single oral dose of sildenafil 25 mg on Cycle 1 Day 11.
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
4
|
4
|
3
|
4
|
4
|
29
|
5
|
5
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
4
|
2
|
4
|
2
|
1
|
3
|
3
|
13
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
2
|
2
|
1
|
1
|
16
|
2
|
5
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
PF-06747775 200 mg QD Group
Participants received a single oral dose of PF-06747775 200 mg on Day -4 in lead-in period, followed by continuous oral dosing of PF-06747775 200 mg QD for 21-day cycles (up to a maximum of 165 weeks). PF-06747775 200 mg QD group was a combined group of PF-06747775 200 mg QD + sildenafil 25 mg SD (Phase 1 Sildenafil sub-study), PF-06747775 200 mg QD + esomeprazole/itraconazole (Phase 1 Esomeprazole/Itraconazole sub-study), Japan Lead-in cohort (LIC) and Phase 2 Cohort 1.
|
Phase 1 Sildenafil Sub-study: PF-06747775 300 mg QD + Sildenafil 25 mg SD
Participants received a single oral dose of sildenafil 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 121 weeks) plus a single oral dose of sildenafil 25 mg on Cycle 1 Day 11.
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
2
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal of informed consent
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Transition to compassionate use
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
3
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Early termination of survival follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Termination by sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study For Patients With NSCLC EGFR Mutations (Del 19 or L858R +/- T790M)
Baseline characteristics by cohort
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
PF-06747775 200 mg QD Group
n=29 Participants
Participants received a single oral dose of PF-06747775 200 mg on Day -4 in lead-in period, followed by continuous oral dosing of PF-06747775 200 mg QD for 21-day cycles (up to a maximum of 165 weeks). PF-06747775 200 mg QD group was a combined group of PF-06747775 200 mg QD + sildenafil 25 mg SD (Phase 1 Sildenafil sub-study), PF-06747775 200 mg QD + esomeprazole/itraconazole (Phase 1 Esomeprazole/Itraconazole sub-study), Japan Lead-in cohort (LIC) and Phase 2 Cohort 1.
|
Phase 1 Sildenafil Sub-study: PF-06747775 300 mg QD + Sildenafil 25 mg SD
n=5 Participants
Participants received a single oral dose of sildenafil 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 121 weeks) plus a single oral dose of sildenafil 25 mg on Cycle 1 Day 11.
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
n=5 Participants
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Primary Diagnoses and Durations
Lung neoplasm malignant
|
3.6 Years
n=5 Participants
|
0.0 Years
n=7 Participants
|
0.0 Years
n=5 Participants
|
0.0 Years
n=4 Participants
|
0.0 Years
n=21 Participants
|
0.0 Years
n=8 Participants
|
0.9 Years
n=8 Participants
|
5.1 Years
n=24 Participants
|
4.9 Years
n=42 Participants
|
0.0 Years
n=42 Participants
|
—
|
—
|
—
|
—
|
3.4 Years
n=24 Participants
|
|
Age, Continuous
|
70.5 Years
n=5 Participants
|
72.0 Years
n=7 Participants
|
62.0 Years
n=5 Participants
|
60.3 Years
n=4 Participants
|
55.7 Years
n=21 Participants
|
63.5 Years
n=8 Participants
|
61.0 Years
n=8 Participants
|
58.8 Years
n=24 Participants
|
63.6 Years
n=42 Participants
|
55.0 Years
n=42 Participants
|
—
|
—
|
—
|
—
|
60.8 Years
n=24 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
19 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
40 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
25 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
16 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
24 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
47 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Unspecified
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
|
Primary Diagnoses and Durations
Adenocarcinoma
|
0.0 Years
n=5 Participants
|
0.0 Years
n=7 Participants
|
5.8 Years
n=5 Participants
|
3.2 Years
n=4 Participants
|
0.0 Years
n=21 Participants
|
0.0 Years
n=8 Participants
|
1.5 Years
n=8 Participants
|
0.2 Years
n=24 Participants
|
0.0 Years
n=42 Participants
|
0.0 Years
n=42 Participants
|
—
|
—
|
—
|
—
|
1.5 Years
n=24 Participants
|
|
Primary Diagnoses and Durations
Lung adenocarcinoma
|
0.0 Years
n=5 Participants
|
9.3 Years
n=7 Participants
|
3.6 Years
n=5 Participants
|
0.0 Years
n=4 Participants
|
0.0 Years
n=21 Participants
|
0.0 Years
n=8 Participants
|
0.0 Years
n=8 Participants
|
1.2 Years
n=24 Participants
|
0.0 Years
n=42 Participants
|
0.9 Years
n=42 Participants
|
—
|
—
|
—
|
—
|
2.7 Years
n=24 Participants
|
|
Primary Diagnoses and Durations
Lung adenocarcinoma stage IV
|
0.0 Years
n=5 Participants
|
3.4 Years
n=7 Participants
|
0.0 Years
n=5 Participants
|
0.0 Years
n=4 Participants
|
0.0 Years
n=21 Participants
|
0.0 Years
n=8 Participants
|
0.0 Years
n=8 Participants
|
0.0 Years
n=24 Participants
|
0.0 Years
n=42 Participants
|
0.0 Years
n=42 Participants
|
—
|
—
|
—
|
—
|
3.4 Years
n=24 Participants
|
|
Primary Diagnoses and Durations
Non-small cell lung cancer stage IV
|
0.0 Years
n=5 Participants
|
0.0 Years
n=7 Participants
|
4.6 Years
n=5 Participants
|
0.0 Years
n=4 Participants
|
0.0 Years
n=21 Participants
|
0.0 Years
n=8 Participants
|
0.0 Years
n=8 Participants
|
0.0 Years
n=24 Participants
|
0.0 Years
n=42 Participants
|
0.0 Years
n=42 Participants
|
—
|
—
|
—
|
—
|
4.6 Years
n=24 Participants
|
|
Primary Diagnoses and Durations
Squamous cell carcinoma
|
0.0 Years
n=5 Participants
|
0.8 Years
n=7 Participants
|
0.0 Years
n=5 Participants
|
0.0 Years
n=4 Participants
|
0.0 Years
n=21 Participants
|
0.0 Years
n=8 Participants
|
0.0 Years
n=8 Participants
|
0.0 Years
n=24 Participants
|
0.0 Years
n=42 Participants
|
0.0 Years
n=42 Participants
|
—
|
—
|
—
|
—
|
0.8 Years
n=24 Participants
|
|
Primary Diagnoses and Durations
Non-small cell lung cancer
|
0.7 Years
n=5 Participants
|
0.0 Years
n=7 Participants
|
0.0 Years
n=5 Participants
|
2.0 Years
n=4 Participants
|
1.0 Years
n=21 Participants
|
2.3 Years
n=8 Participants
|
3.4 Years
n=8 Participants
|
1.7 Years
n=24 Participants
|
2.9 Years
n=42 Participants
|
2.6 Years
n=42 Participants
|
—
|
—
|
—
|
—
|
1.8 Years
n=24 Participants
|
|
Primary Diagnoses and Durations
Adenocarcinoma metastatic
|
0.0 Years
n=5 Participants
|
0.0 Years
n=7 Participants
|
0.0 Years
n=5 Participants
|
0.0 Years
n=4 Participants
|
0.0 Years
n=21 Participants
|
0.0 Years
n=8 Participants
|
0.0 Years
n=8 Participants
|
0.0 Years
n=24 Participants
|
0.0 Years
n=42 Participants
|
2.1 Years
n=42 Participants
|
—
|
—
|
—
|
—
|
2.1 Years
n=24 Participants
|
PRIMARY outcome
Timeframe: 21 days for Phase 1 dose-escalation cohorts and Japan LIC; 42 days for Phase 1b Cohort 2A; 28 days for Phase 1b Cohort 3Population: The analysis population included participants in Phase 1 dose-escalation cohorts, Japan LIC, Phase 1b Cohorts 2A and 3 who were eligible, received study treatment and who either experienced a DLT during the first cycle of PF-06747775 or the first 2 cycles of PF 06747775 plus palbociclib, or completed the DLT observation period.
DLT was defined as any of the following adverse events (AEs) occurring during the first cycle for Phase 1 dose-escalation cohorts, Japan LIC and Phase 1b Cohort 3, or the first 2 cycles for Phase 1b Cohort 2A of treatment, and considered attributable to study intervention: Grade 4 neutropenia \>7 days; febrile neutropenia; Grade \>=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia; Grade \>=3 non-hematologic toxicities; Grade 4 rash, mucositis, or diarrhea; failure to receive at least 70% of planned doses; Grade 3 QTcF prolongation in asymptomatic participants; treatment-related AEs attributable to PF-06747775, palbociclib or both that caused palbociclib treatment delay \>= 10 days or omission of at least 12 doses of the combination. Grade of AE was defined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
n=6 Participants
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
n=5 Participants
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs) During the First Cycle in Phase 1 Dose-escalation Cohorts, Japan LIC and Phase 1b Cohort 3, and First 2 Cycles in Phase 1b Cohort 2A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to end of treatment (maximum of 165 weeks)Population: The response analysis population included all participants who received at least one dose of study medication, had measurable disease and adequate baseline assessment, and at least 1 post baseline assessment during the study.
Number of participants with confirmed OR according to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1. Complete response (CR) was defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) was defined as Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=29 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Confirmed Objective Response (OR) in PF-06747775 200 mg QD Group
CR
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Confirmed Objective Response (OR) in PF-06747775 200 mg QD Group
PR
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 up to the end of study (maximum of 5 years)Population: The response analysis population included all participants who received at least one dose of study medication, had measurable disease and adequate baseline assessment, and at least 1 post baseline assessment during the study.
PFS was based on Kaplan-Meier estimates. PFS was defined as the time from Cycle 1 Day 1 to the date of the first documentation of objective progression (PD) or death due to any cause. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 28 days after last dose of study treatment (maximum of 199 weeks)Population: The safety analysis population included all enrolled participants who received at least one dose of study treatment.
AE = any untoward medical occurrence in participant who received study treatment without regard to possibility of causal relationship. Grade 3 (Severe) events = unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events = death related to an AE. Treatment-emergent events = between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
n=29 Participants
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
n=5 Participants
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
n=5 Participants
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality)
All-causality AEs
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
29 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality)
Grade 3 or 4 AEs
|
1 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
12 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality)
Grade 5 AEs
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 28 days after last dose of study treatment (maximum of 199 weeks)Population: The safety analysis population included all enrolled participants who received at least one dose of study treatment.
Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Grade 3 (Severe) events = unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events = death related to an AE. Treatment-emergent events = between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Treatment-related AEs were determined by the investigator.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
n=29 Participants
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
n=5 Participants
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
n=5 Participants
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related)
Treatment-related AEs
|
2 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
29 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related)
Grade 3 or 4 treatment-related AEs
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
7 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related)
Grade 5 treatment-related AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 28 days after last dose of study treatment (maximum of 199 weeks)Population: The safety analysis population included all enrolled participants who received at least one dose of study treatment.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-related SAEs were determined by the investigator.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
n=29 Participants
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
n=5 Participants
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
n=5 Participants
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) in All Cohorts All Phases
All-causality SAEs
|
2 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Serious Adverse Events (SAEs) in All Cohorts All Phases
Treatment-related SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to the end of treatment (maximum of 195 weeks)Population: The safety analysis population included all enrolled participants who received at least one dose of study treatment.
Laboratory values included hemoglobin, platelets, white blood cell count (WBC), absolute (abs) neutrophils, abs lymphocytes, abs monocytes, abs eosinophils, abs basophils, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (Alk Phos), sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen (BUN) or urea, creatinine, uric acid, glucose, albumin, phosphorous or phosphate, prothrombin time (PT) or international normalized ratio (INR), partial thromboplastin time (PTT), urinalysis and pregnancy test. Grades of laboratory results were defined by NCI CTCAE version 4.03. Grade 3 (Severe) events = unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
n=29 Participants
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
n=5 Participants
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
n=5 Participants
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Hypernatremia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Hypernatremia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Hypoalbuminemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Hypoalbuminemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Hypocalcemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Hypocalcemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Hypoglycemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Hypoglycemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Hypokalemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Hypokalemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Hypomagnesemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Hypomagnesemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Hyponatremia (Grade 3)
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Hyponatremia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Hypophosphatemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Hypophosphatemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Anemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Anemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Hemoglobin increased (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Hemoglobin increased (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Lymphocyte count increased (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Lymphocyte count increased (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Lymphopenia (Grade 3)
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Lymphopenia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Abs neutrophils (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Abs neutrophils (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Platelets (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Platelets (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
WBC (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
WBC (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
ALT (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
ALT (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Alk Phos (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Alk Phos (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
AST (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
AST (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Total bilirubin (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Total bilirubin (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Creatinine (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Creatinine (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Hypercalcemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Hypercalcemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Hyperglycemia (Grade 3)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Hyperglycemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Hyperkalemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Hyperkalemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Hypermagnesemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Hypermagnesemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 4 Day 1 (maximum of 10 weeks)Population: QTcF analysis population included all treated participants who had at least 1 ECG assessment undertaken pre dose and 1 post dose at steady state in triplicate.
Number of participants meeting categorical criteria of QTcF values when PF-06747775 was given as a single agent in Phase 1 dose-escalation cohorts, PF-06747775 200 mg QD group (only participants in Phase 2 Cohort 1 and Japan LIC were eligible for QTcF within this combined group), and in combination with palbociclib and avelumab in Phase 1b/2 Cohorts 2A, 2B and 3. Criteria for categorization of QTcF were defined as: maximum values 450 - \<480 msec, 480 - \<500 msec and \>=500 msec.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
n=9 Participants
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
n=5 Participants
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab.
>=500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab.
450 msec - <480 msec
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab.
480 msec - <500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 4 Day 1 (maximum of 10 weeks)Population: QTcB analysis population included all treated participants who had at least 1 ECG assessment undertaken pre dose and 1 post dose at steady state in triplicate.
Number of participants meeting categorical criteria of QTcB values when PF-06747775 was given as a single agent in Phase 1 dose-escalation cohorts, PF-06747775 200 mg QD group (only participants in Phase 2 Cohort 1 and Japan LIC were eligible for QTcB within this combined group), and in combination with palbociclib and avelumab in Phase 1b/2 Cohorts 2A, 2B and 3. Criteria for categorization of QTcB were defined as: maximum values 450 - \<480 msec, 480 - \<500 msec and \>=500 msec.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
n=9 Participants
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
n=5 Participants
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab.
450 msec - <480 msec
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab.
480 msec - <500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab.
>=500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to end of treatment (maximum of 195 weeks)Population: The response analysis population included all participants who received at least one dose of study medication, had measurable disease and adequate baseline assessment, and at least 1 post baseline assessment during the study.
Number of participants in Phase 1 cohorts with confirmed and unconfirmed OR according to RECIST v1.1. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. PR was defined as Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Stable was defined as not qualifying for CR, PR or PD. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm. Indeterminate was defined as progression not documented.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
n=5 Participants
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts
CR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts
PR
|
2 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts
Stable / No response
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts
PD
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts
Indeterminate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to end of treatment (maximum of 108 weeks)Population: The response analysis population included all participants who received at least one dose of study medication, had measurable disease and adequate baseline assessment, and at least 1 post baseline assessment during the study.
ORR was defined as percentage of participants with OR based assessment of CR or PR according to RECIST v1.1 that must have been confirmed ≥4 weeks later. Participants who did not have an on treatment radiographic tumor assessment due to early progression, who received anti tumor treatment other than the study medication prior to reaching a CR or PR, or who died, progressed, or dropped out for any reason prior to reaching a CR or PR were counted as non responders in the assessment of ORR. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. PR was defined as Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=5 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) in Phase 1b/2 Cohorts 2A, 2B and 3
|
40.0 Percentage of participants
Interval 7.6 to 81.1
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 up to the end of study (maximum of 5 years)Population: The response analysis population included all participants who received at least one dose of study medication, had measurable disease and adequate baseline assessment, and at least 1 post baseline assessment during the study.
PFS was based on Kaplan-Meier estimates. PFS was defined as the time from Cycle 1 Day 1 to the date of the first documentation of PD or death due to any cause. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=29 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PFS in PF-06747775 200 mg QD Group, Phase 1b Cohorts 2A and 3
|
8.1 Months
Interval 5.4 to 23.3
|
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|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to the end of study (maximum of 5 years)Population: The response analysis population included all participants who received at least one dose of study medication, had measurable disease and adequate baseline assessment, and at least 1 post baseline assessment during the study.
DOR was the time from the date of first documentation of confirmed CR or PR to the date of first documentation of PD or death due to any cause. If tumor progression data included more than 1 date, the first date was used. DOR (months) = \[progression/death date - first date of OR + 1\]/30.4. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. PR was defined as Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Stable was defined as not qualifying for CR, PR or PD. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=29 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=5 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Objective Response (DOR) in Phase 1b/2 Cohorts
|
8.322 Months
Interval 2.8 to 33.59
|
11.069 Months
Interval 9.7 to 12.43
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to the end of study (maximum of 5 years)Population: The response analysis population included all participants who received at least one dose of study medication, had measurable disease and adequate baseline assessment, and at least 1 post baseline assessment during the study.
OS probability was based on Kaplan-Meier method. OS was defined as the time from the start date to date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=9 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS) Probability at 12 Months in Phase 1b/2 Cohorts
|
87.5 Percentage of participants
Interval 50.0 to 97.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1, 2, 4, 6, 8, 24, 48 and 72 hours post-dose on Day -8 (+/- 3 days) in lead-in period for Phase 1 dose-escalation cohorts and on Day -4 in lead-in period for Phase 2 Cohort 1Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Plasma area under the curve from zero to infinite time (AUCinf) of PF-06747775 as a single agent after single dose on Day -8 lead-in period in Phase 1 dose-escalation cohorts and on Day -4 lead-in period in Phase 2 Cohort 1. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
n=2 Participants
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Area Under the Curve From Zero to Infinite Time (AUCinf) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1
|
1618 ng*hr/mL
Geometric Coefficient of Variation 32
|
3195 ng*hr/mL
Geometric Coefficient of Variation 34
|
9536 ng*hr/mL
Geometric Coefficient of Variation 45
|
24100 ng*hr/mL
Geometric Coefficient of Variation 23
|
21160 ng*hr/mL
Geometric Coefficient of Variation 28
|
46170 ng*hr/mL
Geometric Coefficient of Variation 60
|
42650 ng*hr/mL
Geometric Coefficient of Variation 26
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Geometric mean was not reported for n\<3.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1, 2, 4, 6, 8, 24, 48 and 72 hours post-dose on Day -8 (+/- 3 days) in lead-in period for Phase 1 dose-escalation cohorts and on Day -4 in lead-in period for Phase 2 Cohort 1Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Cmax of PF-06747775 as a single agent after single dose on Day -8 lead-in period in Phase 1 dose-escalation cohorts and on Day -4 lead-in period in Phase 2 Cohort 1. Cmax was the maximum concentration after dose administration observed directly from the data.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
n=3 Participants
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Concentration Observed After Dose Administration (Cmax) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1
|
369.3 ng/mL
Geometric Coefficient of Variation 55
|
570.6 ng/mL
Geometric Coefficient of Variation 14
|
2242 ng/mL
Geometric Coefficient of Variation 29
|
3599 ng/mL
Geometric Coefficient of Variation 13
|
3205 ng/mL
Geometric Coefficient of Variation 19
|
5556 ng/mL
Geometric Coefficient of Variation 27
|
6517 ng/mL
Geometric Coefficient of Variation 12
|
2829 ng/mL
Geometric Coefficient of Variation 132
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1, 2, 4, 6, 8, 24, 48 and 72 hours post-dose on Day -8 (+/- 3 days) in lead-in period for Phase 1 dose-escalation cohorts and on Day -4 in lead-in period for Phase 2 Cohort 1Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Half-life (t1/2) of PF-06747775 as a single agent after single dose on Day -8 lead-in period in Phase 1 dose-escalation cohorts and on Day -4 lead-in period in Phase 2 Cohort 1. t1/2 was defined as the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
n=2 Participants
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Half-life (t1/2) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1
|
13.12 hrs
Standard Deviation 9.615
|
12.97 hrs
Standard Deviation 7.921
|
6.870 hrs
Standard Deviation 1.972
|
9.907 hrs
Standard Deviation 10.304
|
4.113 hrs
Standard Deviation 0.611
|
9.453 hrs
Standard Deviation 9.654
|
6.213 hrs
Standard Deviation 3.466
|
NA hrs
Standard Deviation NA
Mean was not reported for n\<3.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1, 2, 4, 6, 8, 24, 48 and 72 hours post-dose on Day -8 (+/- 3 days) in lead-in period for Phase 1 dose-escalation cohorts and on Day -4 in lead-in period for Phase 2 Cohort 1Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Apparent clearance (CL/F) of PF-06747775 as a single agent after single dose on Day -8 lead-in period in Phase 1 dose-escalation cohorts and on Day -4 lead-in period in Phase 2 Cohort 1. CL/F was calculated as: CL/F = dose / AUCinf. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
n=2 Participants
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1
|
15.43 L/hr
Geometric Coefficient of Variation 32
|
15.64 L/hr
Geometric Coefficient of Variation 34
|
15.72 L/hr
Geometric Coefficient of Variation 45
|
11.41 L/hr
Geometric Coefficient of Variation 23
|
14.19 L/hr
Geometric Coefficient of Variation 28
|
9.756 L/hr
Geometric Coefficient of Variation 60
|
14.09 L/hr
Geometric Coefficient of Variation 25
|
NA L/hr
Geometric Coefficient of Variation NA
Geometric mean was not reported for n\<3.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1, 2, 4, 6, 8, 24, 48 and 72 hours post-dose on Day -8 (+/- 3 days) in lead-in period for Phase 1 dose-escalation cohorts and on Day -4 in lead-in period for Phase 2 Cohort 1Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Vz/F was defined as apparent volume of distribution. Vz/F was calculated as: Vz/F = dose / (AUCinf \* kel). kel was defined as terminal phase rate constant and calculated by a linear regression of the log-linear concentration-time curve. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
n=2 Participants
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution (Vz/F) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1
|
248.1 L
Geometric Coefficient of Variation 106
|
260.3 L
Geometric Coefficient of Variation 94
|
151.0 L
Geometric Coefficient of Variation 75
|
114.8 L
Geometric Coefficient of Variation 103
|
83.81 L
Geometric Coefficient of Variation 44
|
97.50 L
Geometric Coefficient of Variation 57
|
114.8 L
Geometric Coefficient of Variation 67
|
NA L
Geometric Coefficient of Variation NA
Geometric mean was not reported for n\<3.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Cycle 1 Day 11Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Pre-dose concentration at steady state (Ctrough) of PF-06747775 as a single agent after multiple doses on Cycle 1 Day 11 in Phase 1 dose-escalation cohorts, Phase 2 Cohorts 1 and 2B. Ctrough was defined as pre-dose concentration during multiple dosing and observed directly from data.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
n=3 Participants
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pre-dose Concentration at Steady State (Ctrough) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B
|
5.951 ng/mL
Geometric Coefficient of Variation 83
|
15.38 ng/mL
Geometric Coefficient of Variation 142
|
52.66 ng/mL
Geometric Coefficient of Variation 127
|
194.55 ng/mL
Geometric Coefficient of Variation 55
|
80.08 ng/mL
Geometric Coefficient of Variation 64
|
283.1 ng/mL
Geometric Coefficient of Variation 169
|
63.23 ng/mL
Geometric Coefficient of Variation 1158
|
46.84 ng/mL
Geometric Coefficient of Variation 302
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 6, 8, 24 hours post-dose on Cycle 1 Day 11 for Phase 1 dose-escalation cohorts; 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose on Cycle 1 Day 11 for Phase 2 Cohorts 1 and 2BPopulation: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
n=3 Participants
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve at Steady State (AUCtau) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B
|
2067 ng*hr/mL
Geometric Coefficient of Variation 33
|
3605 ng*hr/mL
Geometric Coefficient of Variation 60
|
14830 ng*hr/mL
Geometric Coefficient of Variation 74
|
31490 ng*hr/mL
Geometric Coefficient of Variation 48
|
21500 ng*hr/mL
Geometric Coefficient of Variation 28
|
40770 ng*hr/mL
Geometric Coefficient of Variation 36
|
43060 ng*hr/mL
Geometric Coefficient of Variation 56
|
19990 ng*hr/mL
Geometric Coefficient of Variation 122
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 6, 8, 24 hours post-dose on Cycle 1 Day 11 for Phase 1 dose-escalation cohorts; 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose for Phase 2 Cohorts 1 and 2BPopulation: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
CL/F of PF-06747775 as a single agent after multiple doses on Cycle 1 Day 11 in Phase 1 dose-escalation cohorts, Phase 2 Cohorts 1 and 2B. CL/F was calculated as: CL/F = dose / AUCtau. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
n=3 Participants
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
CL/F of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B
|
12.11 L/hr
Geometric Coefficient of Variation 33
|
13.85 L/hr
Geometric Coefficient of Variation 60
|
10.11 L/hr
Geometric Coefficient of Variation 74
|
8.737 L/hr
Geometric Coefficient of Variation 48
|
13.92 L/hr
Geometric Coefficient of Variation 28
|
11.03 L/hr
Geometric Coefficient of Variation 35
|
12.97 L/hr
Geometric Coefficient of Variation 42
|
10.01 L/hr
Geometric Coefficient of Variation 123
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -8 (dose-escalation cohorts) or -4 (Cohort 1); 0 (pre-dose), 1, 2, 4, 6, 8 (except for Cohort 1) and 24 hours post dose on Cycle 1 Day 11 for dose-escalation cohorts, Cohorts 1 and 2BPopulation: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Rac was calculated as: Rac = (steady state AUCtau) / (single dose AUC24). AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method. AUC24 was defined as area under the plasma concentration-time curve from time 0 to 24 hours.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
n=3 Participants
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Observed Accumulation Ratio (Rac) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B
|
1.467 Ratio
Geometric Coefficient of Variation 27
|
1.202 Ratio
Geometric Coefficient of Variation 24
|
1.620 Ratio
Geometric Coefficient of Variation 40
|
1.538 Ratio
Geometric Coefficient of Variation 25
|
1.035 Ratio
Geometric Coefficient of Variation 19
|
1.108 Ratio
Geometric Coefficient of Variation 13
|
1.113 Ratio
Geometric Coefficient of Variation 16
|
1.491 Ratio
Geometric Coefficient of Variation 27
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1, 2, 4, 6, 8, 24, 48 and 72 hours post dose on Lead-in Day -8 (dose-escalation cohorts) or Day -4 (Cohort 1); 0 (pre-dose), 1, 2, 4, 6, 8 (except for Cohort 1) and 24 hours post dose on Cycle 1 Day 11Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Steady state accumulation ratio (Rss) of PF-06747775 as a single agent after multiple doses on Cycle 1 Day 11 in Phase 1 dose-escalation cohorts, Phase 2 Cohorts 1 and 2B. Rss was calculated as: Rss = (steady state AUCtau) / (single dose AUCinf). AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
n=2 Participants
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Steady State Accumulation Ratio (Rss) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B
|
1.378 Ratio
Geometric Coefficient of Variation 28
|
1.130 Ratio
Geometric Coefficient of Variation 24
|
1.554 Ratio
Geometric Coefficient of Variation 43
|
1.576 Ratio
Geometric Coefficient of Variation 29
|
1.016 Ratio
Geometric Coefficient of Variation 19
|
1.108 Ratio
Geometric Coefficient of Variation 14
|
1.086 Ratio
Geometric Coefficient of Variation 15
|
NA Ratio
Geometric Coefficient of Variation NA
Geometric mean was not reported for n\<3.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose on Day -8 (+/- 3 days) in lead-in periodPopulation: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
AUCinf of sildenafil dosed alone and in combination with PF-06747775 200 mg or 300 mg on Day -8 lead-in period in Phase 1 Sildenafil sub-study. AUCinf was defined as area under the plasma concentration versus time curve from zero to extrapolated infinite time.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=7 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=5 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUCinf of Sildenafil Dosed Alone on Day -8 lead-in Period in Phase 1 Sildenafil Sub-study
|
757.7 ng*hr/mL
Geometric Coefficient of Variation 61
|
459.1 ng*hr/mL
Geometric Coefficient of Variation 41
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post dose on Day -8 (+/- 3 days) in lead-in periodPopulation: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Cmax values for sildenafil were analyzed using a mixed effects model with treatment as fixed effect and participant as random effect to estimate the effect of steady state PF-06747775 on sildenafil exposure. Cmax was the maximum concentration after dose administration observed directly from the data.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=7 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=5 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of Sildenafil Dosed Alone on Day -8 lead-in Period in Phase 1 Sildenafil Sub-study
|
182.5 ng/mL
Geometric Coefficient of Variation 80
|
148.4 ng/mL
Geometric Coefficient of Variation 46
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post dose on Day -8 (+/- 3 days) in lead-in periodPopulation: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
CL/F of sildenafil dosed alone on Day -8 lead-in period in Phase 1 Sildenafil sub-study. CL/F was calculated as: CL/F = dose / AUCinf. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=7 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=5 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
CL/F of Sildenafil Dosed Alone on Day -8 lead-in Period in Phase 1 Sildenafil Sub-study
|
33.03 L/hr
Geometric Coefficient of Variation 61
|
54.39 L/hr
Geometric Coefficient of Variation 41
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 11 (+/- 4 days)Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
AUCinf of sildenafil dosed alone and in combination with PF-06747775 200 mg or 300 mg on Day -8 lead-in period in Phase 1 Sildenafil sub-study. AUCinf was defined as area under the plasma concentration versus time curve from zero to extrapolated infinite time.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=6 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=5 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUCinf of Sildenafil Dosed in Combination With PF-06747775 200 mg or 300 mg on Cycle 1 Day 11 in Phase 1 Sildenafil Sub-study
|
429.1 ng*hr/mL
Geometric Coefficient of Variation 84
|
298.3 ng*hr/mL
Geometric Coefficient of Variation 39
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 11 (+/- 4 days)Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Cmax values for sildenafil were analyzed using a mixed effects model with treatment as fixed effect and participant as random effect to estimate the effect of steady state PF-06747775 on sildenafil exposure.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=6 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=5 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of Sildenafil Dosed in Combination With PF-06747775 200 mg or 300 mg on Cycle 1 Day 11 in Phase 1 Sildenafil Sub-study
|
204.5 ng/mL
Geometric Coefficient of Variation 67
|
87.57 ng/mL
Geometric Coefficient of Variation 29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 11 (+/- 4 days)Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
CL/F of sildenafil dosed alone and in combination with PF-06747775 200 mg or 300 mg on Day -8 lead-in period and Cycle 1 Day 11 in Phase 1 Sildenafil sub-study. CL/F was calculated as: CL/F = dose / AUCinf. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=6 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=5 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
CL/F of Sildenafil Dosed in Combination With PF-06747775 200 mg or 300 mg on Cycle 1 Day 11 in Phase 1 Sildenafil Sub-study
|
58.20 L/hr
Geometric Coefficient of Variation 84
|
83.88 L/hr
Geometric Coefficient of Variation 40
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post dose of PF-06747775 on Cycle 1 Days 8 and 9Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
AUCtau of PF-06747775 at the RP2D under fed and overnight fasted conditions in Phase 1 Food Effect and Rifampin DDI sub-study. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post dose of PF-06747775 on Cycle 1 Days 8 and 9Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Cmax of PF-06747775 at the RP2D under fed and overnight fasted conditions in Phase 1 Food Effect and Rifampin DDI sub-study. Cmax was the maximum concentration after dose administration observed directly from the data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose of PF-06747775 on Cycle 1 Days 8, 13 and 21Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
AUCtau of PF-06747775 at the RP2D when dosed alone and after esomeprazole/itraconazole treatment in Phase 1 Esomeprazole-Itraconazole DDI sub-study. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=13 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUCtau of PF-06747775 at RP2D When Dosed Alone and After Esomeprazole/Itraconazole Treatment in Phase 1 Esomeprazole-Itraconazole DDI Sub-study
Cycle 1 Day 8
|
17200 ng*hr/mL
Geometric Coefficient of Variation 45
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUCtau of PF-06747775 at RP2D When Dosed Alone and After Esomeprazole/Itraconazole Treatment in Phase 1 Esomeprazole-Itraconazole DDI Sub-study
Cycle 1 Day 13
|
14340 ng*hr/mL
Geometric Coefficient of Variation 35
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUCtau of PF-06747775 at RP2D When Dosed Alone and After Esomeprazole/Itraconazole Treatment in Phase 1 Esomeprazole-Itraconazole DDI Sub-study
Cycle 1 Day 21
|
10010 ng*hr/mL
Geometric Coefficient of Variation 54
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose of PF-06747775 on Cycle 1 Days 8, 13 and 21Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Cmax of PF-06747775 at RP2D when dosed alone and after esomeprazole/itraconazole treatment in Phase 1 Esomeprazole-Itraconazole DDI sub-study. Cmax was the maximum concentration after dose administration observed directly from the data.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=13 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of PF-06747775 at RP2D When Dosed Alone and After Esomeprazole/Itraconazole Treatment in Phase 1 Esomeprazole-Itraconazole DDI Sub-study
Cycle 1 Day 8
|
2597 ng/mL
Geometric Coefficient of Variation 46
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax of PF-06747775 at RP2D When Dosed Alone and After Esomeprazole/Itraconazole Treatment in Phase 1 Esomeprazole-Itraconazole DDI Sub-study
Cycle 1 Day 13
|
2015 ng/mL
Geometric Coefficient of Variation 37
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax of PF-06747775 at RP2D When Dosed Alone and After Esomeprazole/Itraconazole Treatment in Phase 1 Esomeprazole-Itraconazole DDI Sub-study
Cycle 1 Day 21
|
1592 ng/mL
Geometric Coefficient of Variation 68
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post dose of PF-06747775 on Cycle 1 Day 21Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
AUCtau of PF-06747775 at RP2D dosed alone and after rifampin treatment in Phase 1 Food Effect and Rifampin DDI sub-study. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post dose of PF-06747775 on Cycle 1 Day 21Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Cmax of PF-06747775 at RP2D dosed alone and after rifampin treatment in Phase 1 Food Effect and Rifampin DDI sub-study. Cmax was the maximum concentration after dose administration observed directly from the data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 6 and 24 hours post dose on Cycle 1 Day 15Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
AUCtau of PF-06747775 following multiple doses when given in combination with palbociclib on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUCtau of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B
|
17040 ng*hr/mL
Geometric Coefficient of Variation 91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 6 and 24 hours post dose on Cycle 1 Day 15Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Cmax of PF-06747775 following multiple doses when given in combination with palbociclib on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B. Cmax was the maximum concentration after dose administration observed directly from the data.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B
|
2757 ng/mL
Geometric Coefficient of Variation 87
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 6 and 24 hours post dose on Cycle 1 Day 15Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
CL/F of PF-06747775 following multiple doses when given in combination with palbociclib on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B. CL/F was calculated as: CL/F = dose / AUCtau. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
CL/F of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B
|
11.74 L/hr
Geometric Coefficient of Variation 91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Ctrough of PF-06747775 following multiple doses when given in combination with palbociclib on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B. Ctrough was defined as pre-dose concentration during multiple dosing and observed directly from data.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ctrough of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B
Cycle 1 Day 15
|
57.73 ng/mL
Geometric Coefficient of Variation 91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B
Cycle 2 Day 1
|
29.44 ng/mL
Geometric Coefficient of Variation 58
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B
Cycle 2 Day 15
|
48.39 ng/mL
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B
Cycle 3 Day 1
|
42.68 ng/mL
Geometric Coefficient of Variation 56
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B
Cycle 4 Day 1
|
35.12 ng/mL
Geometric Coefficient of Variation 38
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Cycle 1 Day 15Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Ctrough of PF-06747775 following multiple doses when given in combination with avelumab on Cycle 1 Day 15 in Phase 1b Cohort 3. Ctrough was defined as pre-dose concentration during multiple dosing and observed directly from data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 6 and 24 hours post dose on Cycle 1 Day 15Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
AUCtau of palbociclib following multiple doses when given in combination with PF-06747775 on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUCtau of Palbociclib Following Multiple Doses When Given in Combination With PF-06747775 on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B
|
1420 ng*hr/mL
Geometric Coefficient of Variation 42
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 6 and 24 hours post dose on Cycle 1 Day 15Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Cmax of palbociclib following multiple doses when given in combination with PF-06747775 on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B. Cmax was the maximum concentration after dose administration observed directly from the data.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of Palbociclib Following Multiple Doses When Given in Combination With PF-06747775 on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B
|
78.93 ng/mL
Geometric Coefficient of Variation 39
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Ctrough of palbociclib following multiple doses when given in combination with PF-06747775 on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b/2 Cohorts 2A and 2B. Ctrough was defined as pre-dose concentration during multiple dosing and observed directly from data.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ctrough of Palbociclib Following Multiple Doses When Given in Combination With PF-06747775 on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B
Cycle 1 Day 15
|
40.46 ng/mL
Geometric Coefficient of Variation 59
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough of Palbociclib Following Multiple Doses When Given in Combination With PF-06747775 on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B
Cycle 2 Day 1
|
28.83 ng/mL
Geometric Coefficient of Variation 57
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough of Palbociclib Following Multiple Doses When Given in Combination With PF-06747775 on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B
Cycle 2 Day 15
|
32.80 ng/mL
Geometric Coefficient of Variation 42
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough of Palbociclib Following Multiple Doses When Given in Combination With PF-06747775 on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B
Cycle 3 Day 1
|
23.82 ng/mL
Geometric Coefficient of Variation 34
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough of Palbociclib Following Multiple Doses When Given in Combination With PF-06747775 on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B
Cycle 4 Day 1
|
25.85 ng/mL
Geometric Coefficient of Variation 54
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1-3 and Cycle 1 Day 15Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Ctrough of avelumab when given in combination with PF-06747775 on Day 1 of Cycles 1-3 and Cycle 1 Day 15 in Phase 1b Cohort 3. Ctrough was defined as pre-dose concentration during multiple dosing and observed directly from data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of infusion of avelumab on Day 1 of Cycles 1-3 and Cycle 1 Day 15Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Cmax of avelumab when given in combination with PF-06747775 on Day 1 of Cycles 1-3 and Cycle 1 Day 15 in Phase 1b Cohort 3. Cmax was the end of infusion peak concentration observed directly from data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: The biomarker analysis set is defined as all participants in the safety analysis set who had at least one screening and post treatment biomarker assessment.
Number of participants with EGFR mutations in tumor tissue in all cohorts all phases. EGFR mutation assessments in tumor tissue included the mutations statuses of exon 19 deletion (del 19), exon 21 (L858R), G719X, L861Q, S768I, exon 20 insertions and T790M.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
n=29 Participants
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
n=5 Participants
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
n=5 Participants
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
exon 20 insertions · Negative
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
26 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
S768I · Not done
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
del 19 · Negative
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
10 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
del 19 · Positive
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
16 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
del 19 · Uninformative
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
del 19 · Not done
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
L858R · Negative
|
3 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
17 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
L858R · Positive
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
9 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
L858R · Uninformative
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
L858R · Not done
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
G719X · Negative
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
26 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
G719X · Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
G719X · Uninformative
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
G719X · Not done
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
L861Q · Negative
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
26 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
L861Q · Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
L861Q · Uninformative
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
L861Q · Not done
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
S768I · Negative
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
26 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
S768I · Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
S768I · Uninformative
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
exon 20 insertions · Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
exon 20 insertions · Uninformative
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
exon 20 insertions · Not done
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
T790M · Negative
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
19 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
T790M · Positive
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
T790M · Uninformative
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
T790M · Not done
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: The biomarker analysis set is defined as all participants in the safety analysis set who had at least one screening and post treatment biomarker assessment.
Number of participants with EGFR mutations in plasma in all cohorts all phases. EGFR mutation assessments in plasma included the mutations statuses of exon 19 deletion (del 19), exon 21 (L858R) and T790M.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
n=4 Participants
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
n=29 Participants
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
n=5 Participants
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
n=5 Participants
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases
L858R · Negative
|
4 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
21 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases
L858R · Positive
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
8 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases
L858R · Uninformative
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases
T790M · Negative
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
19 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases
T790M · Positive
|
1 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
10 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases
T790M · Uninformative
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases
del 19 (2235_49DEL15) · Negative
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
26 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases
del 19 (2235_49DEL15) · Positive
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases
del 19 (2235_49DEL15) · Uninformative
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases
del 19 (2236_50DEL15) · Negative
|
4 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
22 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases
del 19 (2236_50DEL15) · Positive
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases
del 19 (2236_50DEL15) · Uninformative
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases
del 19 (2237_55DELINST) · Negative
|
4 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
26 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases
del 19 (2237_55DELINST) · Positive
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases
del 19 (2237_55DELINST) · Uninformative
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases
del 19 (2239_48DELINSC) · Negative
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
29 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases
del 19 (2239_48DELINSC) · Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases
del 19 (2239_48DELINSC) · Uninformative
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases
del 19 (2240_54DEL15) · Negative
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
28 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases
del 19 (2240_54DEL15) · Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases
del 19 (2240_54DEL15) · Uninformative
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases
del 19 (2240_57DEL18) · Negative
|
4 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
27 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases
del 19 (2240_57DEL18) · Positive
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases
del 19 (2240_57DEL18) · Uninformative
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1-3 and Cycle 1 Day 15Population: The immunogenicity analysis set included participants who had at least one ADA sample collected for avelumab.
Number of participants with positive serum ADA of avelumab at pre-dose on Day 1 of Cycles 1-3 and Cycle 1 Day 15 in Phase 1b Cohort 3.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4 for Japan LIC RP2D cohort, Lead-in Day -7 and Cycle 1 Day 1 for Japan LIC PK cohortPopulation: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
AUCinf of PF-06747775 following a 200 mg single dose on Lead-in Day -4 in Japan LIC RP2D cohort and Cycle 1 Day 1 in Japan LIC PK cohort, and following a 100 mg single dose on Lead-in Day -7 in Japan LIC PK cohort. AUCinf was defined as area under the plasma concentration versus time curve from zero to extrapolated infinite time.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUCinf of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort
PF-06747775 200 mg SD
|
13610 ng*hr/mL
Geometric Coefficient of Variation 39
|
16060 ng*hr/mL
Geometric Coefficient of Variation 4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUCinf of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort
PF-06747775 100 mg SD
|
—
|
6880 ng*hr/mL
Geometric Coefficient of Variation 23
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4 for Japan LIC RP2D cohort, Lead-in Day -7 and Cycle 1 Day 1 for Japan LIC PK cohortPopulation: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Cmax of PF-06747775 following a 200 mg single dose on Lead-in Day -4 in Japan LIC RP2D cohort and Cycle 1 Day 1 in Japan LIC PK cohort, and following a 100 mg single dose on Lead-in Day -7 in Japan LIC PK cohort. Cmax was the maximum concentration observed from data.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort
PF-06747775 200 mg SD
|
3128 ng/mL
Geometric Coefficient of Variation 22
|
2795 ng/mL
Geometric Coefficient of Variation 36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort
PF-06747775 100 mg SD
|
—
|
1407 ng/mL
Geometric Coefficient of Variation 26
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4 for Japan LIC RP2D cohort, Lead-in Day -7 and Cycle 1 Day 1 for Japan LIC PK cohortPopulation: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Vz/F of PF-06747775 following a 200 mg single dose on Lead-in Day -4 in Japan LIC RP2D cohort and Cycle 1 Day 1 in Japan LIC PK cohort, and following a 100 mg single dose on Lead-in Day -7 in Japan LIC PK cohort. Vz/F was defined as apparent volume of distribution. Vz/F was calculated as: Vz/F = dose / (AUCinf \* kel). kel was defined as terminal phase rate constant and calculated by a linear regression of the log-linear concentration-time curve. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Vz/F of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort
PF-06747775 200 mg SD
|
90.94 L
Geometric Coefficient of Variation 91
|
96.23 L
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Vz/F of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort
PF-06747775 100 mg SD
|
—
|
108.2 L
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4 for Japan LIC RP2D cohort, Lead-in Day -7 and Cycle 1 Day 1 for Japan LIC PK cohortPopulation: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
t1/2 of PF-06747775 following a 200 mg single dose on Lead-in Day -4 in Japan LIC RP2D cohort and Cycle 1 Day 1 in Japan LIC PK cohort, and following a 100 mg single dose on Lead-in Day -7 in Japan LIC PK cohort. t1/2 was defined as the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
t1/2 of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort
PF-06747775 200 mg SD
|
4.527 hrs
Standard Deviation 1.662
|
5.563 hrs
Standard Deviation 1.981
|
—
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—
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—
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—
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—
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—
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—
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—
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|
t1/2 of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort
PF-06747775 100 mg SD
|
—
|
5.317 hrs
Standard Deviation 1.596
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Cycle 1 Day 11 (Japan LIC RP2D cohort) and Day 15 (Japan LIC PK cohort)Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
AUCtau of PF-06747775 following multiple doses on Cycle 1 Day 11 in Japan LIC RP2D cohort and Cycle 1 Day 15 in Japan LIC PK cohort. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUCtau of PF-06747775 Following Multiple Doses in Japan LIC RP2D and PK Cohorts
|
17680 ng*hr/mL
Geometric Coefficient of Variation 35
|
23300 ng*hr/mL
Geometric Coefficient of Variation 32
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Cycle 1 Day 11 (Japan LIC RP2D cohort) and Day 15 (Japan LIC PK cohort)Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Ctrough of PF-06747775 following multiple doses on Cycle 1 Day 11 in Japan LIC RP2D cohort and Cycle 1 Day 15 in Japan LIC PK cohort. Ctrough was defined as pre-dose concentration during multiple dosing and observed directly from data.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ctrough of PF-06747775 Following Multiple Doses in Japan LIC RP2D and PK Cohorts
|
48.91 ng/mL
Geometric Coefficient of Variation 14
|
79.75 ng/mL
Geometric Coefficient of Variation 91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4, Cycle 1 Day 11 for Japan LIC RP2D cohort, Cycle 1 Days 1 and 15 for Japan LIC PK cohortPopulation: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Rac of PF-06747775 following multiple doses on Cycle 1 Day 11 in Japan LIC RP2D cohort and Cycle 1 Day 15 in Japan LIC PK cohort. Rac was calculated as: Rac = (steady state AUCtau) / (single dose AUC24). AUC24 was defined as area under the plasma concentration-time curve from time 0 to 24 hours following single dose. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Rac of PF-06747775 Following Multiple Doses in Japan LIC RP2D and PK Cohorts
|
1.322 Ratio
Geometric Coefficient of Variation 50
|
1.766 Ratio
Geometric Coefficient of Variation 22
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4, Cycle 1 Day 11 for Japan LIC RP2D cohort, Cycle 1 Days 1 and 15 for Japan LIC PK cohortPopulation: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Rss of PF-06747775 following multiple doses on Cycle 1 Day 11 in Japan RP2D cohort and Cycle 1 Day 15 in Japan PK cohort. Rss was calculated as: Rss = (steady state AUCtau) / (single dose AUCinf). AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Rss of PF-06747775 Following Multiple Doses in Japan LIC RP2D and PK Cohorts
|
1.298 Ratio
Geometric Coefficient of Variation 49
|
1.689 Ratio
Geometric Coefficient of Variation 25
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4, Cycle 1 Day 11 for Japan LIC RP2D cohort, Lead-in Day-7, Days 1 and 15 for Japan LIC PK cohortPopulation: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
CL/F of PF-06747775 following single dose on Lead-in Day -4 in Japan LIC RP2D cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK cohort, and following multiple doses on Cycle 1 Day 11 in Japan LIC RP2D cohort and on Cycle 1 Day 15 in Japan LIC PK cohort. CL/F was calculated as: CL/F = dose/AUCinf for single dose or dose/AUCtau for multiple doses. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time.
Outcome measures
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 Participants
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
Japan LIC
Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
CL/F of PF-06747775 Following Single and Multiple Doses in Japan LIC RP2D and PK Cohorts
PF-06747775 200 mg SD
|
14.64 L/hr
Geometric Coefficient of Variation 40
|
12.46 L/hr
Geometric Coefficient of Variation 4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
CL/F of PF-06747775 Following Single and Multiple Doses in Japan LIC RP2D and PK Cohorts
PF-06747775 100 mg SD
|
—
|
14.57 L/hr
Geometric Coefficient of Variation 24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
CL/F of PF-06747775 Following Single and Multiple Doses in Japan LIC RP2D and PK Cohorts
PF-06747775 200 mg QD
|
11.32 L/hr
Geometric Coefficient of Variation 35
|
8.594 L/hr
Geometric Coefficient of Variation 32
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1 Dose-escalation: PF-06747775 25 mg QD
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 1 Dose-escalation: PF-06747775 50 mg QD
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1 Dose-escalation: PF-06747775 150 mg QD
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 1 Dose-escalation: PF-06747775 275 mg QD
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 1 Dose-escalation: PF-06747775 300 mg QD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1 Dose-escalation: PF-06747775 450 mg QD
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Phase 1 Dose-escalation: PF-06747775 600 mg QD
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
PF-06747775 200 mg QD Group
Serious events: 3 serious events
Other events: 29 other events
Deaths: 0 deaths
Phase 1 Sildenafil Sub-study: PF-06747775 300 mg QD + Sildenafil 25 mg SD
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 2 Cohort 2B: PF-06747775 Single Agent
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1b Cohort 3: PF-06747775 + Avelumab
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 participants at risk
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 participants at risk
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
n=4 participants at risk
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
n=4 participants at risk
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
n=3 participants at risk
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
n=4 participants at risk
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
n=4 participants at risk
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
PF-06747775 200 mg QD Group
n=29 participants at risk
Participants received a single oral dose of PF-06747775 200 mg on Day -4 in lead-in period, followed by continuous oral dosing of PF-06747775 200 mg QD for 21-day cycles (up to a maximum of 165 weeks). PF-06747775 200 mg QD group was a combined group of PF-06747775 200 mg QD + sildenafil 25 mg SD (Phase 1 Sildenafil sub-study), PF-06747775 200 mg QD + esomeprazole/itraconazole (Phase 1 Esomeprazole/Itraconazole sub-study), Japan Lead-in cohort (LIC) and Phase 2 Cohort 1.
|
Phase 1 Sildenafil Sub-study: PF-06747775 300 mg QD + Sildenafil 25 mg SD
n=5 participants at risk
Participants received a single oral dose of sildenafil 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 121 weeks) plus a single oral dose of sildenafil 25 mg on Cycle 1 Day 11.
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
n=5 participants at risk
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Cardiac disorders
Angina pectoris
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Cardiac disorders
Tachycardia
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Asthenia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Disease progression
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Joint abscess
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Pneumonia
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
Other adverse events
| Measure |
Phase 1 Dose-escalation: PF-06747775 25 mg QD
n=4 participants at risk
Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
|
Phase 1 Dose-escalation: PF-06747775 50 mg QD
n=3 participants at risk
Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
|
Phase 1 Dose-escalation: PF-06747775 150 mg QD
n=4 participants at risk
Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
|
Phase 1 Dose-escalation: PF-06747775 275 mg QD
n=4 participants at risk
Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
|
Phase 1 Dose-escalation: PF-06747775 300 mg QD
n=3 participants at risk
Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
|
Phase 1 Dose-escalation: PF-06747775 450 mg QD
n=4 participants at risk
Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
|
Phase 1 Dose-escalation: PF-06747775 600 mg QD
n=4 participants at risk
Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
|
PF-06747775 200 mg QD Group
n=29 participants at risk
Participants received a single oral dose of PF-06747775 200 mg on Day -4 in lead-in period, followed by continuous oral dosing of PF-06747775 200 mg QD for 21-day cycles (up to a maximum of 165 weeks). PF-06747775 200 mg QD group was a combined group of PF-06747775 200 mg QD + sildenafil 25 mg SD (Phase 1 Sildenafil sub-study), PF-06747775 200 mg QD + esomeprazole/itraconazole (Phase 1 Esomeprazole/Itraconazole sub-study), Japan Lead-in cohort (LIC) and Phase 2 Cohort 1.
|
Phase 1 Sildenafil Sub-study: PF-06747775 300 mg QD + Sildenafil 25 mg SD
n=5 participants at risk
Participants received a single oral dose of sildenafil 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 121 weeks) plus a single oral dose of sildenafil 25 mg on Cycle 1 Day 11.
|
Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD
n=5 participants at risk
Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
|
Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin
Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 + Palbociclib
Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 2 Cohort 2B: PF-06747775 Single Agent
Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
|
Phase 1b Cohort 3: PF-06747775 + Avelumab
Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Diplopia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
13.8%
4/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
100.0%
4/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
13.8%
4/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
40.0%
2/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
40.0%
2/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Eye disorders
Cataract
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Eye disorders
Conjunctival oedema
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Eye disorders
Corneal erosion
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.9%
2/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
10.3%
3/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Eye disorders
Eye irritation
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Eye disorders
Eyelid rash
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Eye disorders
Eyelids pruritus
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Eye disorders
Growth of eyelashes
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Eye disorders
Pterygium
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Eye disorders
Trichomegaly
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Anal inflammation
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
10.3%
3/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
40.0%
2/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
17.2%
5/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
100.0%
4/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
100.0%
3/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
100.0%
4/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
100.0%
4/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
69.0%
20/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
80.0%
4/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
100.0%
5/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.9%
2/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
60.0%
3/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.9%
2/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
66.7%
2/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
75.0%
3/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
17.2%
5/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
40.0%
2/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
40.0%
2/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
75.0%
3/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
100.0%
3/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
55.2%
16/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
40.0%
2/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
60.0%
3/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Asthenia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
17.2%
5/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Chest discomfort
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Chills
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Fatigue
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
10.3%
3/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
40.0%
2/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Candida infection
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Malaise
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
17.2%
5/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
40.0%
2/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Oedema
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Pain
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Peripheral swelling
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Pyrexia
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
10.3%
3/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Anal fungal infection
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Cellulitis
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
66.7%
2/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
13.8%
4/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.9%
2/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Paronychia
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
75.0%
3/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
66.7%
2/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
75.0%
3/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
79.3%
23/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
80.0%
4/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
80.0%
4/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
100.0%
4/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.9%
2/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.9%
2/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
24.1%
7/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
13.8%
4/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Blood calcium decreased
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
48.3%
14/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
40.0%
2/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
40.0%
2/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Blood urea increased
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
40.0%
2/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.9%
2/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.9%
2/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
40.0%
2/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
13.8%
4/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
60.0%
3/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
13.8%
4/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
60.0%
3/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Weight increased
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
10.3%
3/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
60.0%
3/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
13.8%
4/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
40.0%
2/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
40.0%
2/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
40.0%
2/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.9%
2/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.9%
2/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.9%
2/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
40.0%
2/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.9%
2/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
17.2%
5/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
60.0%
3/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
75.0%
3/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
13.8%
4/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Migraine
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
10.3%
3/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.9%
2/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.9%
2/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
75.0%
3/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.9%
2/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
40.0%
2/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Reproductive system and breast disorders
Pelvic pain
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.9%
2/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Reproductive system and breast disorders
Vulvovaginal rash
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
17.2%
5/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
75.0%
3/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
13.8%
4/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
40.0%
2/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.9%
2/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
60.0%
3/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
75.0%
3/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
75.0%
3/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
13.8%
4/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.9%
2/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.9%
2/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
75.0%
3/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
75.0%
3/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
31.0%
9/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
60.0%
3/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
40.0%
2/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.9%
2/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
75.0%
3/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
24.1%
7/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
66.7%
2/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
75.0%
3/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
51.7%
15/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
40.0%
2/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
40.0%
2/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
100.0%
4/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
75.0%
3/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
48.3%
14/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
40.0%
2/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.4%
1/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
75.0%
3/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
75.0%
3/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
66.7%
2/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
27.6%
8/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
40.0%
2/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
40.0%
2/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
75.0%
3/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
100.0%
4/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
100.0%
3/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
100.0%
4/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
44.8%
13/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
80.0%
4/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
60.0%
3/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
24.1%
7/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Vascular disorders
Haematoma
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
2/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
10.3%
3/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/29 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
—
0/0 • Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER