Trial Outcomes & Findings for Gemcitabine and Nab-paclitaxel Combined With Momelotinib in Participants With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (NCT NCT02101021)
NCT ID: NCT02101021
Last Updated: 2023-06-29
Results Overview
Dose limiting toxicities were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Dose limiting toxicities referred to toxicities experienced during the first 28 days (Cycle 1) of treatment that were judged to be clinically significant and related to study treatment. No statistical analysis was planned or performed for this endpoint.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
25 participants
Primary outcome timeframe
Up to 28 Days
Results posted on
2023-06-29
Participant Flow
Participants were enrolled at study sites in the United States (US). The first participant was screened on 02 June 2014. The last study visit occurred on 10 April 2017.
38 participants were screened. Data submitted represent analysis performed on data collected in the lead-in phase by the Study Termination Date, 10 April 2017. The study was discontinued before initiation of the randomized treatment phase, therefore no data were collected for the randomized treatment phase.
Participant milestones
| Measure |
MMB Dose Level 1
Momelotinib (MMB) 100 mg tablet once daily + albumin-bound (nab)-paclitaxel plus gemcitabine (nab-P+G) (1000+1000 mg/m\^2) intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 2
MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 3
MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 4
MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 5
MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
4
|
7
|
3
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
7
|
3
|
4
|
Reasons for withdrawal
| Measure |
MMB Dose Level 1
Momelotinib (MMB) 100 mg tablet once daily + albumin-bound (nab)-paclitaxel plus gemcitabine (nab-P+G) (1000+1000 mg/m\^2) intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 2
MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 3
MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 4
MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 5
MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
4
|
3
|
6
|
0
|
3
|
|
Overall Study
Withdrew Consent from study
|
1
|
1
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
1
|
0
|
1
|
1
|
1
|
Baseline Characteristics
Gemcitabine and Nab-paclitaxel Combined With Momelotinib in Participants With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
Baseline characteristics by cohort
| Measure |
MMB Dose Level 1
n=7 Participants
MMB 100 mg tablet once daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 2
n=4 Participants
MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 3
n=7 Participants
MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 4
n=3 Participants
MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 5
n=4 Participants
MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 12.32 • n=93 Participants
|
63.5 years
STANDARD_DEVIATION 12.12 • n=4 Participants
|
64.7 years
STANDARD_DEVIATION 8.79 • n=27 Participants
|
52.0 years
STANDARD_DEVIATION 5.00 • n=483 Participants
|
59.0 years
STANDARD_DEVIATION 9.13 • n=36 Participants
|
60.7 years
STANDARD_DEVIATION 10.21 • n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
8 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
17 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
22 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
24 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
25 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Up to 28 DaysPopulation: DLT-Evaluable Analysis Set: participants in the Safety Analysis Set who completed all treatment and safety procedures through Day 28, inclusive, or experienced a DLT prior to Day 29. Participants in the DLT-Evaluable Analysis Set with available data were analyzed.
Dose limiting toxicities were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Dose limiting toxicities referred to toxicities experienced during the first 28 days (Cycle 1) of treatment that were judged to be clinically significant and related to study treatment. No statistical analysis was planned or performed for this endpoint.
Outcome measures
| Measure |
MMB Dose Level 1
n=6 Participants
MMB 100 mg tablet once daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 2
n=3 Participants
MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 3
n=6 Participants
MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 4
n=3 Participants
MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 5
n=3 Participants
MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
|---|---|---|---|---|---|
|
Lead-In Phase: Percentage of Participants Experiencing Treatment-Emergent Dose Limiting Toxicity (DLT) Adverse Events
|
16.7 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to the Date of Death or Censoring, up to 3 yearsPopulation: The study was discontinued before initiation of the randomized treatment phase.
Overall survival was defined as the time interval from first dose date of MMB to death from any cause
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to the Date of Death or Censoring, up to 3 yearsPopulation: All Enrolled Analysis Set
Overall survival was defined as the time interval from first dose date of MMB to death from any cause
Outcome measures
| Measure |
MMB Dose Level 1
n=7 Participants
MMB 100 mg tablet once daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 2
n=4 Participants
MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 3
n=7 Participants
MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 4
n=3 Participants
MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 5
n=4 Participants
MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
|---|---|---|---|---|---|
|
Lead-In Phase: Overall Survival (OS)
|
12.4 Months
Interval 3.9 to 22.2
|
5.1 Months
Interval 3.7 to 11.3
|
8.7 Months
Interval 7.3 to 18.3
|
5.6 Months
Interval 4.8 to 18.1
|
7.1 Months
Interval 5.9 to 12.0
|
SECONDARY outcome
Timeframe: Baseline up to the Date of Event or Censoring, up to 3 yearsPopulation: All Enrolled Analysis Set
Progression-free survival was defined as the time interval from the first dose of MMB to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression is progression based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria v1.1. Data from survival, non-progressing participants will be censored at the earliest of the time of initiation of anti-tumor therapy other than the study treatment or the last time that lack of definitive disease progression was objectively documented while on study.
Outcome measures
| Measure |
MMB Dose Level 1
n=7 Participants
MMB 100 mg tablet once daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 2
n=4 Participants
MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 3
n=7 Participants
MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 4
n=3 Participants
MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 5
n=4 Participants
MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
|---|---|---|---|---|---|
|
Lead-In Phase: Progression-Free Survival (PFS)
|
5.3 Months
Interval 1.4 to 7.4
|
3.2 Months
Interval 1.9 to 4.8
|
5.5 Months
Interval 5.3 to 7.2
|
5.3 Months
Interval 0.0 to 13.0
|
5.5 Months
Interval 4.5 to 10.1
|
SECONDARY outcome
Timeframe: Baseline up to the Last Tumor Assessment Date, up to 3 yearsPopulation: All Enrolled Analysis Set
The ORR was defined as the proportion of participants who achieved a best overall response (BOR) during MMB therapy of complete response (CR) or partial response (PR) as assessed by RECIST v1.1.
Outcome measures
| Measure |
MMB Dose Level 1
n=7 Participants
MMB 100 mg tablet once daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 2
n=4 Participants
MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 3
n=7 Participants
MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 4
n=3 Participants
MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 5
n=4 Participants
MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
|---|---|---|---|---|---|
|
Lead-In Phase: Overall Response Rate (ORR)
Complete Response (CR)
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Lead-In Phase: Overall Response Rate (ORR)
Partial Response (PR)
|
2 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline up to the Date of Event or Censoring, up to 3 yearsPopulation: The study was discontinued before initiation of the randomized treatment phase.
Progression-free survival was defined as the time interval from the first dose of MMB to the earlier of the first documentation of definitive disease progression or death from any cause
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to the Last Tumor Assessment Date, up to 3 yearsPopulation: The study was discontinued before initiation of the randomized treatment phase.
The ORR was defined as the proportion of subjects who achieved a best overall response (BOR) during MMB therapy of complete response (CR) or partial response (PR)
Outcome measures
Outcome data not reported
Adverse Events
MMB Dose Level 1
Serious events: 4 serious events
Other events: 7 other events
Deaths: 4 deaths
MMB Dose Level 2
Serious events: 3 serious events
Other events: 4 other events
Deaths: 3 deaths
MMB Dose Level 3
Serious events: 5 serious events
Other events: 7 other events
Deaths: 6 deaths
MMB Dose Level 4
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
MMB Dose Level 5
Serious events: 4 serious events
Other events: 4 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
MMB Dose Level 1
n=7 participants at risk
MMB 100 mg tablet once daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 2
n=4 participants at risk；n=7 participants at risk
MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 3
n=7 participants at risk
MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 4
n=3 participants at risk
MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 5
n=4 participants at risk
MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Generalised oedema
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
42.9%
3/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
28.6%
2/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Septic shock
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
Other adverse events
| Measure |
MMB Dose Level 1
n=7 participants at risk
MMB 100 mg tablet once daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 2
n=4 participants at risk；n=7 participants at risk
MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 3
n=7 participants at risk
MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 4
n=3 participants at risk
MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
MMB Dose Level 5
n=4 participants at risk
MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m\^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
|
|---|---|---|---|---|---|
|
Infections and infestations
Bronchiolitis
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Candida infection
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Ear infection
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
85.7%
6/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
50.0%
2/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
57.1%
4/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
66.7%
2/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
75.0%
3/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
66.7%
2/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
75.0%
3/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
50.0%
2/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Intracardiac mass
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Eye disorders
Dry eye
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
28.6%
2/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
42.9%
3/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
75.0%
3/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
28.6%
2/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
75.0%
3/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
42.9%
3/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
66.7%
2/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
75.0%
3/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
42.9%
3/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
75.0%
3/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
42.9%
3/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
100.0%
3/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
75.0%
3/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
71.4%
5/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
100.0%
4/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
57.1%
4/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
100.0%
3/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
75.0%
3/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatic failure
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
3/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
75.0%
3/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
57.1%
4/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
75.0%
3/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Chills
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
28.6%
2/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Early satiety
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Face oedema
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
71.4%
5/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
75.0%
3/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
85.7%
6/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
66.7%
2/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
100.0%
4/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Gait disturbance
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Generalised oedema
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Malaise
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
50.0%
2/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Oedema
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
57.1%
4/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
28.6%
2/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
66.7%
2/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
75.0%
3/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Peripheral swelling
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
42.9%
3/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
50.0%
2/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
42.9%
3/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
75.0%
3/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Temperature intolerance
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
42.9%
3/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
28.6%
2/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
50.0%
2/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
42.9%
3/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Viral infection
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Liver function test increased
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Lymphocyte count decreased
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Platelet count decreased
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
28.6%
2/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Troponin increased
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Urine output decreased
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
66.7%
2/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
White blood cell count decreased
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
28.6%
2/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
50.0%
2/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
28.6%
2/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
66.7%
2/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
28.6%
2/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
42.9%
3/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
57.1%
4/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
28.6%
2/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
28.6%
2/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
28.6%
2/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
50.0%
2/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
42.9%
3/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
66.7%
2/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
28.6%
2/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
28.6%
2/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
28.6%
2/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
50.0%
2/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
50.0%
2/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
42.9%
3/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
50.0%
2/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness exertional
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysaesthesia
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
42.9%
3/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
42.9%
3/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
66.7%
2/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
50.0%
2/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Extrapyramidal disorder
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
42.9%
3/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Lethargy
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
42.9%
3/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
66.7%
2/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
75.0%
3/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
42.9%
3/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
28.6%
2/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
66.7%
2/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Tremor
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
28.6%
2/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
28.6%
2/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
28.6%
2/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Personality change
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
50.0%
2/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
28.6%
2/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
50.0%
2/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
50.0%
2/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
42.9%
3/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
50.0%
2/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
42.9%
3/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
66.7%
2/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
28.6%
2/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail bed disorder
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
42.9%
3/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
50.0%
2/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Embolism venous
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
28.6%
2/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
66.7%
2/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
75.0%
3/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
28.6%
2/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Venous thrombosis limb
|
14.3%
1/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Sierra Oncology, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Sierra Oncology in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER