Trial Outcomes & Findings for A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Endocrine Tumors of the Gastrointestinal Tract. (NCT NCT00448136)
NCT ID: NCT00448136
Last Updated: 2015-01-22
Results Overview
PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
83 participants
Primary outcome timeframe
Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
Results posted on
2015-01-22
Participant Flow
Participant milestones
| Measure |
Bevacizumab + 5-fluorouracil (5-FU) + Streptozocin
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) on Days 1 and 22; 5-FU 400 mg per square meter per day (mg/m\^2/day) IV on Days 1 through 5; and streptozocin 500 mg/m\^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
|
Bevacizumab + Capecitabine
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m\^2, tablets, orally (PO), twice daily (BID) on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
49
|
|
Overall Study
COMPLETED
|
30
|
41
|
|
Overall Study
NOT COMPLETED
|
4
|
8
|
Reasons for withdrawal
| Measure |
Bevacizumab + 5-fluorouracil (5-FU) + Streptozocin
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) on Days 1 and 22; 5-FU 400 mg per square meter per day (mg/m\^2/day) IV on Days 1 through 5; and streptozocin 500 mg/m\^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
|
Bevacizumab + Capecitabine
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m\^2, tablets, orally (PO), twice daily (BID) on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
|
|---|---|---|
|
Overall Study
Death
|
3
|
8
|
|
Overall Study
Investigator's decision (progression)
|
1
|
0
|
Baseline Characteristics
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Endocrine Tumors of the Gastrointestinal Tract.
Baseline characteristics by cohort
| Measure |
Bevacizumab + 5-FU + Streptozocin
n=34 Participants
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m\^2/day IV on Days 1 through 5; and streptozocin 500 mg/m\^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
|
Bevacizumab + Capecitabine
n=49 Participants
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m\^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.93 years
STANDARD_DEVIATION 10.63 • n=5 Participants
|
61.64 years
STANDARD_DEVIATION 9.20 • n=7 Participants
|
59.29 years
STANDARD_DEVIATION 10.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Screening, every 3 months during treatment, every 6 months during follow-up to 2 yearsPopulation: ITT population
PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression.
Outcome measures
| Measure |
Bevacizumab + 5-FU + Streptozocin
n=34 Participants
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m\^2/day IV on Days 1 through 5; and streptozocin 500 mg/m\^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
|
Bevacizumab + Capecitabine
n=49 Participants
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m\^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
|
|---|---|---|
|
Progression-Free Survival (PFS) - Percentage of Participants With an Event
|
52.9 percentage of participants
|
53.1 percentage of participants
|
PRIMARY outcome
Timeframe: Screening, every 3 months during treatment, every 6 months during follow-up to 2 yearsPopulation: ITT population
PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to RECIST using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression. Median PFS was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Bevacizumab + 5-FU + Streptozocin
n=34 Participants
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m\^2/day IV on Days 1 through 5; and streptozocin 500 mg/m\^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
|
Bevacizumab + Capecitabine
n=49 Participants
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m\^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
|
|---|---|---|
|
PFS - Time to Event
|
23.7 months
Interval 13.1 to
The upper limit for the median PFS was not estimated because it was longer than the latest censoring time, and therefore was not achieved.
|
23.4 months
Interval 13.2 to
The upper limit for the median PFS was not estimated because it was longer than the latest censoring time, and therefore was not achieved.
|
PRIMARY outcome
Timeframe: Screening, every 3 months during treatment, every 6 months during follow-up to 2 yearsPopulation: ITT population
PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to RECIST using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression.
Outcome measures
| Measure |
Bevacizumab + 5-FU + Streptozocin
n=34 Participants
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m\^2/day IV on Days 1 through 5; and streptozocin 500 mg/m\^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
|
Bevacizumab + Capecitabine
n=49 Participants
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m\^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
|
|---|---|---|
|
PFS - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months
12 months
|
76 percentage of participants
|
65 percentage of participants
|
|
PFS - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months
24 months
|
50 percentage of participants
|
48 percentage of participants
|
SECONDARY outcome
Timeframe: Screening, every 3 months during treatment, every 6 months during follow-up to 2 yearsPopulation: ITT population. Data were missing from centralized review for 1 participant.
Best overall response defined as best response recorded during the study as defined according to RECIST; performed by the investigator and by centralized review. Complete response (CR): complete disappearance of all target lesions and non-target disease. All lesions, both target and non-target, must have decreased to normal (short axis, less than \[\<\]10 millimeters \[mm\]). No new lesions. Partial response (PR): greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter (LD) was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease (SD): not qualifying for CR, PR, or Progressive Disease (PD). PD: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.
Outcome measures
| Measure |
Bevacizumab + 5-FU + Streptozocin
n=34 Participants
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m\^2/day IV on Days 1 through 5; and streptozocin 500 mg/m\^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
|
Bevacizumab + Capecitabine
n=49 Participants
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m\^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
|
|---|---|---|
|
Percentage of Participants With a Response by Best Overall Response
PR (Investigator)
|
55.9 percentage of participants
Interval 39.2 to 72.6
|
18.4 percentage of participants
Interval 7.5 to 29.2
|
|
Percentage of Participants With a Response by Best Overall Response
PR (Centralized review)
|
51.5 percentage of participants
Interval 34.5 to 68.6
|
12.5 percentage of participants
Interval 3.1 to 21.9
|
|
Percentage of Participants With a Response by Best Overall Response
SD (Investigator)
|
44.1 percentage of participants
Interval 27.4 to 60.8
|
69.4 percentage of participants
Interval 56.5 to 82.3
|
|
Percentage of Participants With a Response by Best Overall Response
SD (Centralized review)
|
48.5 percentage of participants
Interval 31.4 to 65.5
|
81.3 percentage of participants
Interval 70.2 to 92.3
|
|
Percentage of Participants With a Response by Best Overall Response
PD (Investigator)
|
0 percentage of participants
Interval 0.0 to 0.0
|
8.2 percentage of participants
Interval 0.5 to 15.8
|
|
Percentage of Participants With a Response by Best Overall Response
PD (Centralized review)
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With a Response by Best Overall Response
Not evaluable (Investigator)
|
0 percentage of participants
Interval 0.0 to 0.0
|
4.1 percentage of participants
Interval 0.0 to 9.6
|
|
Percentage of Participants With a Response by Best Overall Response
Not evaluable (Centralized review)
|
0 percentage of participants
Interval 0.0 to 0.0
|
6.3 percentage of participants
Interval 0.0 to 13.1
|
SECONDARY outcome
Timeframe: Screening, every 3 months during treatment, every 6 months during follow-up to 2 yearsPopulation: ITT population; only participants with a response of CR or PR were included in the analysis.
Determined only for those participants with an overall response (CR or PR) and was defined as the time interval between the response (CR or PR) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.
Outcome measures
| Measure |
Bevacizumab + 5-FU + Streptozocin
n=19 Participants
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m\^2/day IV on Days 1 through 5; and streptozocin 500 mg/m\^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
|
Bevacizumab + Capecitabine
n=9 Participants
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m\^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
|
|---|---|---|
|
Duration of Overall Response (OR) - Percentage of Participants With an Event
|
42.1 percentage of participants
|
22.2 percentage of participants
|
SECONDARY outcome
Timeframe: Screening, every 3 months during treatment, every 6 months during follow-up to 2 yearsPopulation: ITT population; only participants with a response of CR or PR were included in the analysis.
Determined only for those participants with an overall response (CR or PR) and was defined as the time interval between the response (CR or PR) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression. Median duration of OR was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Bevacizumab + 5-FU + Streptozocin
n=19 Participants
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m\^2/day IV on Days 1 through 5; and streptozocin 500 mg/m\^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
|
Bevacizumab + Capecitabine
n=9 Participants
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m\^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
|
|---|---|---|
|
Duration of OR - Time to Event
|
NA months
Interval 11.2 to
Median duration and upper limit of the 95% confidence interval (CI) could not be calculated due to an insufficient number of events.
|
NA months
Interval 3.2 to
Median duration and upper limit of the 95% CI could not be calculated due to an insufficient number of events.
|
SECONDARY outcome
Timeframe: Screening, every 3 months during treatment, every 6 months during follow-up to 2 yearsPopulation: ITT population
Duration of OR was determined only for those participants with an overall response of CR or PR and was defined as the time interval between the response (CR or PR) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.
Outcome measures
| Measure |
Bevacizumab + 5-FU + Streptozocin
n=19 Participants
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m\^2/day IV on Days 1 through 5; and streptozocin 500 mg/m\^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
|
Bevacizumab + Capecitabine
n=9 Participants
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m\^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
|
|---|---|---|
|
Duration of OR - Percentage of Participants With Sustained Response at 12 and 24 Months
12 months
|
74 percentage of participants
|
70 percentage of participants
|
|
Duration of OR - Percentage of Participants With Sustained Response at 12 and 24 Months
24 months
|
55 percentage of participants
|
NA percentage of participants
Not evaluable as data from all participants were censored, or participants had experienced events of progression or death before the 24-month timepoint.
|
SECONDARY outcome
Timeframe: Screening, every 3 months during treatment, every 6 months during follow-up to 2 yearsPopulation: ITT population
Determined only for those participants with overall disease control (CR, PR or SD per RECIST) and was defined as the time interval between the first occurrence of disease control (CR, PR or SD) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.
Outcome measures
| Measure |
Bevacizumab + 5-FU + Streptozocin
n=34 Participants
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m\^2/day IV on Days 1 through 5; and streptozocin 500 mg/m\^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
|
Bevacizumab + Capecitabine
n=43 Participants
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m\^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
|
|---|---|---|
|
Duration of Overall Disease Control (ODC) - Percentage of Participants With an Event
|
52.9 percentage of participants
|
46.5 percentage of participants
|
SECONDARY outcome
Timeframe: Screening, every 3 months during treatment, every 6 months during follow-up to 2 yearsPopulation: ITT population; only participants with a response (CR, PR, or SD) were included in the analysis.
Determined only for those participants with overall control disease (CR, PR, or SD per RECIST) and was defined as the time interval between the first occurrence of disease control (CR, PR or SD) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression. Median time to event was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Bevacizumab + 5-FU + Streptozocin
n=34 Participants
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m\^2/day IV on Days 1 through 5; and streptozocin 500 mg/m\^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
|
Bevacizumab + Capecitabine
n=43 Participants
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m\^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
|
|---|---|---|
|
Duration of ODC - Time to Event
|
22.3 months
Interval 11.9 to
The upper limit of the 95% CI was not estimated because it was longer than the latest censoring time, and therefore was not achieved.
|
23.4 months
Interval 15.1 to
The upper limit of the 95% CI was not estimated because it was longer than the latest censoring time, and therefore was not achieved.
|
SECONDARY outcome
Timeframe: Screening, every 3 months during treatment, every 6 months during follow-up to 2 yearsPopulation: ITT population; only participants with a response (CR, PR, or SD) were included in the analysis.
Duration of ODC was determined only for those participants with overall control disease (CR, PR, or SD per RECIST) and was defined as the time interval between the first occurrence of disease control (CR, PR, or SD) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.
Outcome measures
| Measure |
Bevacizumab + 5-FU + Streptozocin
n=34 Participants
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m\^2/day IV on Days 1 through 5; and streptozocin 500 mg/m\^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
|
Bevacizumab + Capecitabine
n=43 Participants
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m\^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
|
|---|---|---|
|
Duration of ODC - Percentage of Participants Maintaining Disease Control at 12 and 24 Months
12 months
|
68 percentage of participants
|
72 percentage of participants
|
|
Duration of ODC - Percentage of Participants Maintaining Disease Control at 12 and 24 Months
24 months
|
42 percentage of participants
|
NA percentage of participants
Not evaluable as data from all participants were censored, or participants had experienced events of progression or death before the 24-month timepoint.
|
SECONDARY outcome
Timeframe: Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 yearsPopulation: ITT population
OS was defined as the time from the first treatment administration to death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation. Data for participants who were alive at the end of the study were censored at the date of last visit.
Outcome measures
| Measure |
Bevacizumab + 5-FU + Streptozocin
n=34 Participants
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m\^2/day IV on Days 1 through 5; and streptozocin 500 mg/m\^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
|
Bevacizumab + Capecitabine
n=49 Participants
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m\^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
|
|---|---|---|
|
Overall Survival (OS) - Percentage of Participants With an Event
|
14.7 percentage of participants
|
16.3 percentage of participants
|
SECONDARY outcome
Timeframe: Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 yearsPopulation: ITT population
OS was defined as the time from the first treatment administration to death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation. Data for participants who were alive at the end of the study were censored at the date of last visit. Median OS was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Bevacizumab + 5-FU + Streptozocin
n=34 Participants
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m\^2/day IV on Days 1 through 5; and streptozocin 500 mg/m\^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
|
Bevacizumab + Capecitabine
n=49 Participants
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m\^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
|
|---|---|---|
|
OS - Time to Event
|
NA months
Interval 27.0 to
The median (and upper 95% CI) OS was not estimated because it was longer than the latest censoring time, and therefore was not achieved.
|
NA months
The median OS was not estimated because it was longer than the latest censoring time, and therefore was not achieved.
|
SECONDARY outcome
Timeframe: Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 yearsPopulation: ITT population.
OS was defined as the time from the first treatment administration to death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation. Data for participants who were alive at the end of the study were censored at the date of last visit.
Outcome measures
| Measure |
Bevacizumab + 5-FU + Streptozocin
n=34 Participants
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m\^2/day IV on Days 1 through 5; and streptozocin 500 mg/m\^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
|
Bevacizumab + Capecitabine
n=49 Participants
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m\^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
|
|---|---|---|
|
OS - Percentage of Participants Surviving at 12 and 24 Months
24 months
|
88 percentage of participants
|
85 percentage of participants
|
|
OS - Percentage of Participants Surviving at 12 and 24 Months
12 months
|
94 percentage of participants
|
88 percentage of participants
|
SECONDARY outcome
Timeframe: Screening, every 3 months during treatmentPopulation: ITT population; only participants who completed the questionnaire at baseline and who had at least 1 post-baseline assessment were included in the analysis. Number (n) equals (=) the number of participants assessed for the specified parameter at a given visit.
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale \[1 'very poor' to 7 'Excellent'\]). Scores were averaged and transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.
Outcome measures
| Measure |
Bevacizumab + 5-FU + Streptozocin
n=29 Participants
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m\^2/day IV on Days 1 through 5; and streptozocin 500 mg/m\^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
|
Bevacizumab + Capecitabine
n=40 Participants
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m\^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
|
|---|---|---|
|
Global Health Status as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)
12 months (n=13,14)
|
66.03 units on a scale
Standard Deviation 17.83
|
72.62 units on a scale
Standard Deviation 19.46
|
|
Global Health Status as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)
End of treatment (n=13,23)
|
64.74 units on a scale
Standard Deviation 23.36
|
57.97 units on a scale
Standard Deviation 28.48
|
|
Global Health Status as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)
Baseline (n=29,40)
|
65.23 units on a scale
Standard Deviation 23.89
|
65.42 units on a scale
Standard Deviation 20.02
|
|
Global Health Status as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)
3 months (n=20,32)
|
65.83 units on a scale
Standard Deviation 19.48
|
57.03 units on a scale
Standard Deviation 22.41
|
|
Global Health Status as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)
6 months (n=20,24)
|
60.00 units on a scale
Standard Deviation 21.90
|
66.32 units on a scale
Standard Deviation 21.35
|
SECONDARY outcome
Timeframe: Screening, every 3 months during treatmentPopulation: ITT population; only participants who completed the questionnaire at baseline and who had at least 1 post-baseline assessment were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale \[1 'very poor' to 7 'Excellent'\]). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Changes from baseline were categorized as follows: Very much worsening (less than \[\<\]-20); Moderate worsening (greater than or equal to \[≥\]-20 to \<-10); Little worsening (≥-10 to \<-5); No change (≥-5 to less than or equal to \[≤\]5); Little improvement (\>5 to ≤10); Moderate improvement (\>10 to ≤20); and Very much improved (\>20).
Outcome measures
| Measure |
Bevacizumab + 5-FU + Streptozocin
n=20 Participants
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m\^2/day IV on Days 1 through 5; and streptozocin 500 mg/m\^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
|
Bevacizumab + Capecitabine
n=29 Participants
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m\^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
|
|---|---|---|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
3 months, No change (n=20,29)
|
40.0 percentage of participants
|
24.1 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
3 months, Little improving (n=20,29)
|
5.0 percentage of participants
|
3.4 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
3 months, Moderate Improving (n=20,29)
|
15.0 percentage of participants
|
3.4 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
3 months, Very much improving (n=20,29)
|
10.0 percentage of participants
|
10.3 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
12 months, Very much improving (n=12,13)
|
0 percentage of participants
|
7.7 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
End of treatment, Very much improving (n=13,20)
|
7.7 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
3 months, Very much worsening (n=20,29)
|
10.0 percentage of participants
|
17.2 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
3 months, Moderate worsening (n=20,29)
|
10.0 percentage of participants
|
24.1 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
3 months, Little worsening (n=20,29)
|
10.0 percentage of participants
|
17.2 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
6 months, Very much worsening (n=20,22)
|
15.0 percentage of participants
|
22.7 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
6 months, Moderate worsening (n=20,22)
|
10.0 percentage of participants
|
18.2 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
6 months, Little worsening (n=20,22)
|
5.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
6 months, No change (n=20,22)
|
35.0 percentage of participants
|
31.8 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
6 months, Little improving (n=20,22)
|
10.0 percentage of participants
|
13.6 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
6 months, Moderate Improving (n=20,22)
|
15.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
6 months, Very much improving (n=20,22)
|
10.0 percentage of participants
|
13.6 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
12 months, Very much worsening (n=12,13)
|
8.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
12 months, Moderate worsening (n=12,13)
|
8.3 percentage of participants
|
15.4 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
12 months - Little worsening (n=12,13)
|
33.3 percentage of participants
|
15.4 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
12 months, No change (n=12,13)
|
25.0 percentage of participants
|
38.5 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
12 months, Little improving (n=12,13)
|
8.3 percentage of participants
|
7.7 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
12 months, Moderate Improving (n=12,13)
|
16.7 percentage of participants
|
15.4 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
End of treatment, Very much worsening (n=13,20)
|
15.4 percentage of participants
|
15.0 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
End of treatment, Moderate worsening (n=13,20)
|
30.8 percentage of participants
|
5.0 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
End of treatment, Little worsening (n=13,20)
|
0 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
End of treatment, No change (n=13,20)
|
15.4 percentage of participants
|
45.0 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
End of treatment, Little improving (n=13,20)
|
15.4 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
End of treatment, Moderate Improving (n=13,20)
|
15.4 percentage of participants
|
5.0 percentage of participants
|
SECONDARY outcome
Timeframe: Screening, every 3 months during treatmentPopulation: ITT population; only participants who completed the questionnaire at baseline and who had at least 1 post-baseline assessment were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale \[1 'very poor' to 7 'Excellent'\]). Scores averaged, transformed to 0-100 scale; for functional scores, a higher score represents a better level of functioning. For symptom scale scores a higher level represents a more severe level of symptoms.
Outcome measures
| Measure |
Bevacizumab + 5-FU + Streptozocin
n=30 Participants
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m\^2/day IV on Days 1 through 5; and streptozocin 500 mg/m\^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
|
Bevacizumab + Capecitabine
n=43 Participants
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m\^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
|
|---|---|---|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Physical functioning, End of Treatment (n=13,24)
|
82.82 units on a scale
Standard Deviation 20.21
|
79.44 units on a scale
Standard Deviation 19.85
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Dyspnea, 3 months (n=21,33)
|
12.70 units on a scale
Standard Deviation 19.65
|
30.30 units on a scale
Standard Deviation 32.66
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Dyspnea, End of Treatment (n=13,24)
|
20.51 units on a scale
Standard Deviation 28.99
|
23.61 units on a scale
Standard Deviation 30.26
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Financial difficulties, End of treatment (n=13,24)
|
17.95 units on a scale
Standard Deviation 25.88
|
4.17 units on a scale
Standard Deviation 14.95
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Financial difficulties, 3 months (n=22,33)
|
9.09 units on a scale
Standard Deviation 15.19
|
6.06 units on a scale
Standard Deviation 15.49
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Physical functioning, Baseline (n=30,43)
|
90.44 units on a scale
Standard Deviation 13.30
|
87.71 units on a scale
Standard Deviation 14.88
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Physical functioning, 3 months (n=22,33)
|
89.32 units on a scale
Standard Deviation 12.77
|
75.35 units on a scale
Standard Deviation 24.07
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Physical functioning, 6 months (n=21,24)
|
81.98 units on a scale
Standard Deviation 19.75
|
82.50 units on a scale
Standard Deviation 18.21
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Role functioning, Baseline (n=30,43)
|
82.22 units on a scale
Standard Deviation 27.31
|
83.33 units on a scale
Standard Deviation 25.46
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Role functioning, 3 months (n=22,33)
|
85.61 units on a scale
Standard Deviation 21.39
|
62.12 units on a scale
Standard Deviation 33.66
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Role functioning, 6 months (n=21,24)
|
75.40 units on a scale
Standard Deviation 29.16
|
70.83 units on a scale
Standard Deviation 28.34
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Role functioning, End of Treatment (n=13,24)
|
78.21 units on a scale
Standard Deviation 32.90
|
72.92 units on a scale
Standard Deviation 29.00
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Emotional functioning, Baseline (n=30,42)
|
71.94 units on a scale
Standard Deviation 28.32
|
71.89 units on a scale
Standard Deviation 20.50
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Emotional functioning, 3 months (n=21,33)
|
81.48 units on a scale
Standard Deviation 20.53
|
76.01 units on a scale
Standard Deviation 24.27
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Emotional functioning, 6 months (n=21,24)
|
72.62 units on a scale
Standard Deviation 28.28
|
76.04 units on a scale
Standard Deviation 26.27
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Emotional functioning, End of Treatment (n=13,24)
|
77.56 units on a scale
Standard Deviation 23.17
|
73.61 units on a scale
Standard Deviation 24.04
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Cognitive functioning, Baseline (n=30,42)
|
86.67 units on a scale
Standard Deviation 18.26
|
87.30 units on a scale
Standard Deviation 16.38
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Cognitive functioning, 3 months (n=22,33)
|
89.39 units on a scale
Standard Deviation 15.04
|
83.84 units on a scale
Standard Deviation 21.03
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Cognitive functioning, 6 months (n=21,24)
|
83.33 units on a scale
Standard Deviation 21.08
|
82.64 units on a scale
Standard Deviation 18.04
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Cognitive functioning, End of Treatment (n=13,24)
|
83.33 units on a scale
Standard Deviation 22.57
|
81.94 units on a scale
Standard Deviation 25.97
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Social functioning, Baseline (n=30,41)
|
86.11 units on a scale
Standard Deviation 21.48
|
87.40 units on a scale
Standard Deviation 20.34
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Social functioning, 3 months (n=22,33)
|
89.39 units on a scale
Standard Deviation 17.48
|
75.76 units on a scale
Standard Deviation 27.35
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Social functioning, 6 months (n=21,24)
|
81.75 units on a scale
Standard Deviation 26.30
|
83.33 units on a scale
Standard Deviation 21.42
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Social functioning, End of Treatment (n=13,24)
|
84.62 units on a scale
Standard Deviation 24.96
|
81.94 units on a scale
Standard Deviation 21.93
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Fatigue, Baseline (n=30,42)
|
26.30 units on a scale
Standard Deviation 23.61
|
27.25 units on a scale
Standard Deviation 21.70
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Financial difficulties, 6 months (n=21,23)
|
15.87 units on a scale
Standard Deviation 24.99
|
2.90 units on a scale
Standard Deviation 9.60
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Fatigue, 3 months (n=21,33)
|
27.78 units on a scale
Standard Deviation 23.70
|
43.10 units on a scale
Standard Deviation 31.76
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Fatigue, 6 months (n=20,24)
|
36.67 units on a scale
Standard Deviation 29.09
|
37.96 units on a scale
Standard Deviation 23.61
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Fatigue, End of Treatment (n=13,24)
|
34.19 units on a scale
Standard Deviation 28.85
|
34.49 units on a scale
Standard Deviation 32.93
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Nausea and vomiting, Baseline (n=30,42)
|
6.67 units on a scale
Standard Deviation 14.91
|
2.78 units on a scale
Standard Deviation 7.29
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Nausea and vomiting, 3 months (n=22,33)
|
10.61 units on a scale
Standard Deviation 14.13
|
9.60 units on a scale
Standard Deviation 16.15
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Nausea and vomiting, 6 months (n=21,24)
|
8.73 units on a scale
Standard Deviation 17.97
|
7.64 units on a scale
Standard Deviation 12.98
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Nausea and vomiting, End of Treatment (n=13,24)
|
10.26 units on a scale
Standard Deviation 19.88
|
6.25 units on a scale
Standard Deviation 14.59
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Pain, Baseline (n=30,43)
|
14.44 units on a scale
Standard Deviation 19.44
|
21.71 units on a scale
Standard Deviation 27.83
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Pain, 3 months (n=22,33)
|
12.88 units on a scale
Standard Deviation 18.50
|
18.18 units on a scale
Standard Deviation 25.47
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Pain, 6 months (n=21,24)
|
23.02 units on a scale
Standard Deviation 31.83
|
17.36 units on a scale
Standard Deviation 19.95
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Pain, End of Treatment (n=13,24)
|
20.51 units on a scale
Standard Deviation 28.18
|
26.39 units on a scale
Standard Deviation 32.94
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Dyspnea, Baseline (n=30,43)
|
16.67 units on a scale
Standard Deviation 25.89
|
16.28 units on a scale
Standard Deviation 25.59
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Dyspnea, 6 months (n=21,23)
|
19.05 units on a scale
Standard Deviation 24.88
|
23.19 units on a scale
Standard Deviation 29.19
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Insomnia, Baseline (n=30,43)
|
24.44 units on a scale
Standard Deviation 27.59
|
24.03 units on a scale
Standard Deviation 24.48
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Insomnia, 3 months (n=21,33)
|
20.63 units on a scale
Standard Deviation 22.30
|
27.27 units on a scale
Standard Deviation 30.57
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Insomnia, 6 months (n=21,24)
|
33.33 units on a scale
Standard Deviation 34.96
|
29.17 units on a scale
Standard Deviation 30.00
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Insomnia, End of Treatment (n=13,24)
|
23.08 units on a scale
Standard Deviation 25.04
|
30.56 units on a scale
Standard Deviation 33.93
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Appetite loss, Baseline (n=29,42)
|
12.64 units on a scale
Standard Deviation 16.46
|
8.73 units on a scale
Standard Deviation 20.90
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Appetite loss, 3 months (n=22,33)
|
7.58 units on a scale
Standard Deviation 14.30
|
20.20 units on a scale
Standard Deviation 24.92
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Appetite loss, 6 months (n=21,24)
|
15.87 units on a scale
Standard Deviation 27.12
|
25.00 units on a scale
Standard Deviation 26.47
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Appetite loss, End of Treatment (n=13,24)
|
12.82 units on a scale
Standard Deviation 28.99
|
25.00 units on a scale
Standard Deviation 32.97
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Constipation, Baseline (n=27,40)
|
4.94 units on a scale
Standard Deviation 15.20
|
10.00 units on a scale
Standard Deviation 21.62
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Constipation, 3 months (n=21,33)
|
15.87 units on a scale
Standard Deviation 27.12
|
7.07 units on a scale
Standard Deviation 18.18
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Constipation, 6 months (n=21,23)
|
17.46 units on a scale
Standard Deviation 27.12
|
11.59 units on a scale
Standard Deviation 21.58
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Constipation, End of Treatment (n=13,24)
|
12.82 units on a scale
Standard Deviation 21.68
|
13.89 units on a scale
Standard Deviation 25.85
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Diarrhea, Baseline (n=30,41)
|
13.33 units on a scale
Standard Deviation 24.13
|
37.40 units on a scale
Standard Deviation 31.79
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Diarrhea, 3 months (n=22,32)
|
9.09 units on a scale
Standard Deviation 21.04
|
45.83 units on a scale
Standard Deviation 34.65
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Diarrhea, 6 months (n=21,23)
|
6.35 units on a scale
Standard Deviation 17.06
|
43.48 units on a scale
Standard Deviation 30.87
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Diarrhea, End of Treatment (n=12,22)
|
2.78 units on a scale
Standard Deviation 9.62
|
28.79 units on a scale
Standard Deviation 31.36
|
|
EORTC QLQ-C30 Functional and Symptom Scale Scores
Financial difficulties, Baseline (n=30,413)
|
14.44 units on a scale
Standard Deviation 25.80
|
8.13 units on a scale
Standard Deviation 17.92
|
Adverse Events
Bevacizumab + 5-FU + Streptozocin
Serious events: 11 serious events
Other events: 34 other events
Deaths: 0 deaths
Bevacizumab + Capecitabine
Serious events: 13 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab + 5-FU + Streptozocin
n=34 participants at risk
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m\^2/day IV on Days 1 through 5; and streptozocin 500 mg/m\^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
|
Bevacizumab + Capecitabine
n=49 participants at risk
Cycles 1-9 (21-Day cycle): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 2000 mg/m\^2 tablets PO in a divided dose every 12 hours within 30 minutes following a meal, on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.9%
2/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
5.9%
2/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Pyrexia
|
8.8%
3/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
General disorders
General physical health deterioration
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Influenza like illness
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.9%
2/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Post-procedural sepsis
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Hepatobiliary disorders
Jaundice
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Hemorrhage
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Vascular disorders
Thrombotic microangiopathy
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Hemorrhagic stroke
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
Other adverse events
| Measure |
Bevacizumab + 5-FU + Streptozocin
n=34 participants at risk
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m\^2/day IV on Days 1 through 5; and streptozocin 500 mg/m\^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
|
Bevacizumab + Capecitabine
n=49 participants at risk
Cycles 1-9 (21-Day cycle): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 2000 mg/m\^2 tablets PO in a divided dose every 12 hours within 30 minutes following a meal, on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
70.6%
24/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
49.0%
24/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Diarrhoea
|
35.3%
12/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
65.3%
32/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Constipation
|
55.9%
19/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
18.4%
9/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Abdominal pain
|
38.2%
13/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
24.5%
12/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
32.4%
11/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
22.4%
11/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Vomiting
|
32.4%
11/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
14.3%
7/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Haemorrhoids
|
11.8%
4/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
10.2%
5/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Dry mouth
|
11.8%
4/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
8.2%
4/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
8.8%
3/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
8.2%
4/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
14.7%
5/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Stomatitis
|
8.8%
3/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
6.1%
3/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
2/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
6.1%
3/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Flatulence
|
5.9%
2/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Anal fissure
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
6.1%
3/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
6.1%
3/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
6.1%
3/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Gingival bleeding
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Loose tooth
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Gastritis
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Steatorrhoea
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Tongue haematoma
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Asthenia
|
67.6%
23/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
57.1%
28/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Mucosal inflammation
|
41.2%
14/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
34.7%
17/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Oedema peripheral
|
11.8%
4/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
18.4%
9/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Pyrexia
|
23.5%
8/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
8.2%
4/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Fatigue
|
11.8%
4/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
10.2%
5/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Xerosis
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
6.1%
3/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Chest pain
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Chills
|
8.8%
3/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
General disorders
General physical health deterioration
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
6.1%
3/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Influenza like illness
|
8.8%
3/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Malaise
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Oedema
|
5.9%
2/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Catheter site haematoma
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Catheter site pain
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Drug intolerance
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Face oedema
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Implant site inflammation
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Injection site pain
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Mucosal dryness
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Pain
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Psychiatric disorders
Anxiety
|
17.6%
6/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
12.2%
6/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Psychiatric disorders
Insomnia
|
11.8%
4/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
10.2%
5/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Psychiatric disorders
Depression
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
6.1%
3/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
6.1%
3/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Psychiatric disorders
Stress
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Blood and lymphatic system disorders
Anaemia
|
11.8%
4/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
14.3%
7/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.9%
2/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
16.3%
8/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.8%
3/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
12.2%
6/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
10.2%
5/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.9%
2/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
8.2%
4/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Ear and labyrinth disorders
Hypoacusis
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Ear and labyrinth disorders
Vertigo positional
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Reproductive system and breast disorders
Epididymitis
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Reproductive system and breast disorders
Erosive balanitis
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Eye disorders
Visual acuity reduced
|
5.9%
2/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Eye disorders
Visual impairment
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.8%
3/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
10.2%
5/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.9%
2/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.9%
2/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea extertional
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Investigations
Weight decreased
|
11.8%
4/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
10.2%
5/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Investigations
Blood bilirubin abnormal
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Investigations
Alanine aminotransferase abnormal
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Investigations
Alanine aminotransferase increased
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Investigations
Aspartate aminotransferase increased
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Investigations
Blood creatinine decreased
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Investigations
Blood creatinine increased
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Investigations
Cardiac murmur
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Investigations
Creatinine renal clearance decreased
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Investigations
Gamma-glutamyltransferase abnormal
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Investigations
Haemoglobin
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Investigations
Lipase increased
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Hepatobiliary disorders
Portal hypertension
|
5.9%
2/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Hepatobiliary disorders
Cytolytic hepatitis
|
5.9%
2/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Hepatobiliary disorders
Jaundice
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
6.1%
3/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Renal and urinary disorders
Dysuria
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Renal and urinary disorders
Renal failure
|
5.9%
2/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Renal and urinary disorders
Albuminuria
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.7%
5/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
12.2%
6/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.8%
3/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
8.2%
4/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Anorexia
|
5.9%
2/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
8.2%
4/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.5%
8/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
12.2%
6/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.6%
6/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
8.2%
4/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.8%
3/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
6.1%
3/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.9%
2/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
8.2%
4/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.8%
4/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
2/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Headache
|
38.2%
13/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
28.6%
14/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Paraesthesia
|
11.8%
4/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
8.2%
4/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Dizziness
|
8.8%
3/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
8.2%
4/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
8.2%
4/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Dysaesthesia
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Migraine
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Neuropathy peripheral
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Sciatica
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Amnesia
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Burning sensation
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Epilepsy
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Hypokinesia
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Loss of consciousness
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Sensory disturbance
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Transient ischaemic attack
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Tremor
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Nasopharyngitis
|
11.8%
4/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
8.2%
4/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Bronchitis
|
8.8%
3/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
6.1%
3/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Gastroenteritis
|
5.9%
2/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
8.2%
4/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Pharyngitis
|
5.9%
2/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
8.2%
4/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
2/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
8.2%
4/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Sinusitis
|
5.9%
2/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Tonsillitis
|
8.8%
3/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Cystitis
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Herpes simplex
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Infection
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Oral herpes
|
5.9%
2/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Tooth abscess
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Injection site infection
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Candidiasis
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Cholecystitis infective
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Gastroenteritis escherichia coli
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Herpes zoster ophthalmic
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Hordeolum
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Infected cyst
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Post procedural sepsis
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Tracheobronchitis
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Gout
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
6.1%
3/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
8.8%
3/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
5.9%
2/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Hypoglycaemic unconsciousness
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Hyposideraemia
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Malnutrition
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Vitamin K deficiency
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Eye disorders
Conjunctivitis allergic
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Eye disorders
Dry eye
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Eye disorders
Vision blurred
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Vascular disorders
Flushing
|
5.9%
2/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
18.4%
9/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Vascular disorders
Hot flush
|
8.8%
3/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Vascular disorders
Hypotension
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Vascular disorders
Haematoma
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Vascular disorders
Varicose vein
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Vascular disorders
Vein discolouration
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Vascular disorders
Venous insufficiency
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Injury, poisoning and procedural complications
Bite
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Injury, poisoning and procedural complications
Burn of internal organs
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Injury, poisoning and procedural complications
Frostbite
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Injury, poisoning and procedural complications
Iatrogenic injury
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Injury, poisoning and procedural complications
Limb injury
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Injury, poisoning and procedural complications
Radiation mucositis
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Cardiac disorders
Tachycardia
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Cardiac disorders
Cardiac flutter
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Cardiac disorders
Non-obstructive cardiomyopathy
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
17.6%
6/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
63.3%
31/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.7%
5/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
14.3%
7/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.8%
3/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
16.3%
8/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.8%
3/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
8.2%
4/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.8%
3/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.9%
2/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis palmaris and plantaris
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
4.1%
2/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Dyshidrosis
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Nail discomfort
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Nail toxicity
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Skin chapped
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
2.9%
1/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
0.00%
0/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Spider naevus
|
0.00%
0/34 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
2.0%
1/49 • Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request the Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER